Other products from "ICU MEDICAL FLEET SERVICES, LLC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00840619085421 50131-13 50131-13 Optical Module, Black, OPMOD DQA Oximeter 2 ICU Medical
2 10887787009221 2400701 2400701 PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore T PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, 107 Inch FPA Set, administration, intravascular Plum
3 10887787009214 2400601 2400601 PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore T PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 107 Inch FPA Set, administration, intravascular Plum
4 10887787008804 1427329 1427329 Primary PLUM MICRODRIP 150 mL Burette Set, CLAVE Additive Port, 2 CLAVE Y-Sites, Primary PLUM MICRODRIP 150 mL Burette Set, CLAVE Additive Port, 2 CLAVE Y-Sites, Secure Lock, 114 Inch (previously Hospira product) FPA Set, administration, intravascular Plum
5 10887787008798 1427229 1427229 Primary PLUM MICRODRIP 150 mL Burette Set, Prepierced Additive Port, Prepierced Primary PLUM MICRODRIP 150 mL Burette Set, Prepierced Additive Port, Prepierced Secondary Port, 2 Prepierced Y-Sites, Secure Lock, 114 Inch (previously Hospira product) FPA Set, administration, intravascular Lifeshield
6 10887787008774 1955488 1955488 Primary PLUM Set 1.2 Micron Filter, Secure Lock, 119 Inch (previously Hospira product) FPA Set, administration, intravascular Plum
7 10887787008767 1953588 1953588 Primary PLUM Set 1.2 Micron Filter, Secure Lock, 100 Inch (previously Hospira product) FPA Set, administration, intravascular Plum
8 10887787008569 1926188 1926188 Primary Microbore PLUM Set 2 CLAVE Y-Sites, Secure Lock, 98 Inch (previously Hos Primary Microbore PLUM Set 2 CLAVE Y-Sites, Secure Lock, 98 Inch (previously Hospira product) FPA Set, administration, intravascular Lifeshield
9 10887787006497 1137405 1137405 LIFESHIELD Primary PLUM MICRODRIP 50 mL Burette Set Prepierced Injection Site, 0 LIFESHIELD Primary PLUM MICRODRIP 50 mL Burette Set Prepierced Injection Site, 0.2 Micron Filter, Prepierced Y-Site, 101 Inch, Non-DEHP FPA Set, administration, intravascular Plum
10 10887787005728 1495588 1495588 Primary PLUM MICRODRIP 150 mL Burette Set CLAVE Additive Port, 3 CLAVE Y-Sites, Primary PLUM MICRODRIP 150 mL Burette Set CLAVE Additive Port, 3 CLAVE Y-Sites, Backcheck Valve, Secure Lock, 125 Inch (previously Hospira product) FPA Set, administration, intravascular Plum
11 10887787005391 1253848 1253848 Primary PLUM Set CLAVE Secondary Port, CLAVE Y-Site, Secure Lock, 103 Inch (prev Primary PLUM Set CLAVE Secondary Port, CLAVE Y-Site, Secure Lock, 103 Inch (previously Hospira product) FPA Set, administration, intravascular Plum
12 10887787005018 0269428 0269428 Microbore Extension Set, 10 Inch 0.2 Micron Filter, Prepierced Y-Site, Secure Lo Microbore Extension Set, 10 Inch 0.2 Micron Filter, Prepierced Y-Site, Secure Lock (previously Hospira product) FPA Set, administration, intravascular Lifeshield
13 10887787003434 1973201 1973201 Primary PLUM MICRODRIP Set CLAVE Secondary Port, Backcheck Valve, CLAVE Y-Site, Primary PLUM MICRODRIP Set CLAVE Secondary Port, Backcheck Valve, CLAVE Y-Site, Secure Lock, 104 Inch (previously Hospira product) FPA Set, administration, intravascular Plum
14 10887787003236 1495488 1495488 Primary PLUM Set 0.2 Micron Filter, CLAVE Secondary Port, CLAVE Y-Site, Secure L Primary PLUM Set 0.2 Micron Filter, CLAVE Secondary Port, CLAVE Y-Site, Secure Lock, 112 Inch (previously Hospira product) FPA Set, administration, intravascular Plum
15 10887787003205 1495188 1495188 Primary PLUM Set CLAVE Secondary Port, Backcheck Valve, 2 CLAVE Y-Sites, Secure Primary PLUM Set CLAVE Secondary Port, Backcheck Valve, 2 CLAVE Y-Sites, Secure Lock, 104 Inch (previously Hospira product) FPA Set, administration, intravascular Lifeshield
16 10887787009306 B912601 B912601 PRIMARY SET 3 CLAVE Y-Sites, 100 Inch, Non-DEHP FPA Set, administration, intravascular Primary Sets
17 10887787009290 B947301 B947301 Primary MICRODRIP Set 2 CLAVE Y-Sites, 100 Inch, Non-DEHP FPA Set, administration, intravascular Primary Sets
18 10887787009283 B920101 B920101 PRIMARY SET 2 CLAVE Y-Sites, 100 Inch, Non-DEHP FPA Set, administration, intravascular Primary Sets
19 10887787009276 B917801 B917801 PRIMARY SET CLAVE Y-Site, 100 Inch, Non-DEHP FPA Set, administration, intravascular Primary Sets
20 10887787009146 1273002 1273002 Primary Y-Type Blood Set 200 Micron Filter, Bulb Pump, Prepierced Y-Site, Secure Primary Y-Type Blood Set 200 Micron Filter, Bulb Pump, Prepierced Y-Site, Secure Lock, 80 Inch (previously Hospira product) FPA Set, administration, intravascular Blood Set
21 10887787006572 172148 0172148 LATEX-FREE DECANTING SET, 14 Inch For Aseptic Decanting of Fluid from Rubber Sto LATEX-FREE DECANTING SET, 14 Inch For Aseptic Decanting of Fluid from Rubber Stoppered I.V. Solution Containers (previously Hospira product) GBX CATHETER, IRRIGATION Decanting Set
22 10887787009269 2401301 2401301 SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch MRZ ACCESSORIES, PUMP, INFUSION Sapphire
23 10887787009252 2401001 2401001 SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, 119 Inch MRZ ACCESSORIES, PUMP, INFUSION Sapphire
24 10887787009245 2401501 2401501 SAPPHIRE Epidural Set with NRFit Connector Non-Vented, Yellow-Striped Microbore, SAPPHIRE Epidural Set with NRFit Connector Non-Vented, Yellow-Striped Microbore, PAV, 118 Inch MRZ ACCESSORIES, PUMP, INFUSION Sapphire
25 10887787009238 2400801 2400801 SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 117 Inch MRZ ACCESSORIES, PUMP, INFUSION Sapphire
26 10887787009115 6.30.01 160379201 Mednet Software PHC Infusion safety management software 2 ICU Medical MedNet
27 10887787007555 1642101 1642101 SAPPHIRE Y-Type Blood Set 200 Micron Blood Filter, 123 Inch (previously Hospira product) MRZ ACCESSORIES, PUMP, INFUSION Sapphire
28 10887787007531 1640002 1640002 SAPPHIRE Y-Type Blood Set 200 Micron Blood Filter, CLAVE Y-Site, 124 Inch (previ SAPPHIRE Y-Type Blood Set 200 Micron Blood Filter, CLAVE Y-Site, 124 Inch (previously Hospira product) MRZ ACCESSORIES, PUMP, INFUSION Sapphire
29 10887787007517 1639102 1639102 SAPPHIRE Primary 1.2 Micron Filter Set CLAVE Y-Site, 121 Inch (previously Hospira product) MRZ ACCESSORIES, PUMP, INFUSION Sapphire
30 10887787007494 1639002 1639002 SAPPHIRE Primary Piggyback 0.2 Micron Filter Set MICRODRIP, Microbore, 2 CLAVE Y SAPPHIRE Primary Piggyback 0.2 Micron Filter Set MICRODRIP, Microbore, 2 CLAVE Y-Sites, 121 Inch (previously Hospira product) MRZ ACCESSORIES, PUMP, INFUSION Sapphire
31 10887787007487 1638902 1638902 SAPPHIRE Primary Piggyback 0.2 Micron Filter Set 2 CLAVE Y-Sites, 121 Inch (prev SAPPHIRE Primary Piggyback 0.2 Micron Filter Set 2 CLAVE Y-Sites, 121 Inch (previously Hospira product) MRZ ACCESSORIES, PUMP, INFUSION Sapphire
32 10887787007470 1638802 1638802 SAPPHIRE Primary Set 119 Inch (previously Hospira product) MRZ ACCESSORIES, PUMP, INFUSION Sapphire
33 10887787007449 1638401 1638401 SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch (pre SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch (previously Hospira product) MRZ ACCESSORIES, PUMP, INFUSION Sapphire
34 10887787007432 1638303 1638303 SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch (previously Hospira product) MRZ ACCESSORIES, PUMP, INFUSION Sapphire
35 10887787007425 1638102 1638102 SAPPHIRE Primary Set Non-Vented, Microbore, PAV, 118 Inch (previously Hospira product) MRZ ACCESSORIES, PUMP, INFUSION Sapphire
36 10887787007418 1637402 1637402 SAPPHIRE Epidural Set Non-Vented, Yellow-Striped Microbore, PAV, 118 Inch (previ SAPPHIRE Epidural Set Non-Vented, Yellow-Striped Microbore, PAV, 118 Inch (previously Hospira product) MRZ ACCESSORIES, PUMP, INFUSION Sapphire
37 10887787007401 1637302 1637302 SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch (previously Hospira product) MRZ ACCESSORIES, PUMP, INFUSION Sapphire
38 10887787007395 1637201 1637201 SAPPHIRE Non-Vented PCA Set KVO Y-Extension, Microbore, PAV, 115 Inch (previousl SAPPHIRE Non-Vented PCA Set KVO Y-Extension, Microbore, PAV, 115 Inch (previously Hospira product) MRZ ACCESSORIES, PUMP, INFUSION Sapphire
39 10887787007364 1636302 1636302 SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, 119 Inch (pre SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, 119 Inch (previously Hospira product) MRZ ACCESSORIES, PUMP, INFUSION Sapphire
40 10887787007357 1636202 1636202 SAPPHIRE Primary 0.2 Micron Filter Set Microbore, CLAVE Y-Site, 118 Inch (previo SAPPHIRE Primary 0.2 Micron Filter Set Microbore, CLAVE Y-Site, 118 Inch (previously Hospira product) MRZ ACCESSORIES, PUMP, INFUSION Sapphire
41 10887787007319 1633503 1633503 SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch (previously Hospira product) MRZ ACCESSORIES, PUMP, INFUSION Sapphire
42 10887787007302 1633202 1633202 SAPPHIRE Primary 0.2 Micron Filter Set CLAVE Y-Site, 112 Inch (previously Hospira product) MRZ ACCESSORIES, PUMP, INFUSION Sapphire
43 10887787007272 1632502 1632502 SAPPHIRE Primary 0.2 Micron Filter Set 115 Inch (previously Hospira product) MRZ ACCESSORIES, PUMP, INFUSION Sapphire
44 10887787007265 1632402 1632402 SAPPHIRE Primary 1.2 Micron Filter Set CLAVE Y-Site, 114 Inch (previously Hospira product) MRZ ACCESSORIES, PUMP, INFUSION Sapphire
45 10887787007241 1523901 1523901 LATEX-FREE 4-LEAD T-U-R IRRIGATION SET Nonvented Set for Transurethral Resection LATEX-FREE 4-LEAD T-U-R IRRIGATION SET Nonvented Set for Transurethral Resection Procedures 85 inch (216 cm) (previously Hospira product) GBX CATHETER, IRRIGATION Irrigation Set
46 10887787006749 659901 0659901 LATEX-FREE LARGE BORE Y-IRRIGATION SET Nonvented Set 100 Inch (254 cm) For Flexi LATEX-FREE LARGE BORE Y-IRRIGATION SET Nonvented Set 100 Inch (254 cm) For Flexible Irrigation Container Systems (previously Hospira product) GBX CATHETER, IRRIGATION Irrigation Set
47 10887787006732 654401 0654401 LATEX-FREE CYSTOSCOPY/IRRIGATION SET Nonvented, 77 inch (195 cm) for Constant or LATEX-FREE CYSTOSCOPY/IRRIGATION SET Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation For Use with Flexible Irrigation Container System (previously Hospira product) GBX CATHETER, IRRIGATION Irrigation Set
48 10887787006701 654101 0654101 LATEX-FREE SECONDARY IRRIGATION SET For Series Hookup For Use with Flexible Cont LATEX-FREE SECONDARY IRRIGATION SET For Series Hookup For Use with Flexible Container Irrigation Systems (previously Hospira product) GBX CATHETER, IRRIGATION Irrigation Set
49 10887787006695 653665 0653665 LATEX-FREE CATHETER IRRIGATION SET, Convertible Pin, 70 Inch (previously Hospira product) GBX CATHETER, IRRIGATION Irrigation Set
50 10887787006473 300204 0300204 Two-Way Transfer Device, Non-DEHP (previously Hospira product) GBX CATHETER, IRRIGATION Transfer Device
Other products with the same Product Code "MRZ"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 G002RG30 RG3 RG3 SHIFENG MEDICAL TECHNOLOGY CO.，LTD.
2 04086000856720 Z078135 Z078135 Agilia Link 8 is an accessory to Agilia Infusion System as the stacking rack sys Agilia Link 8 is an accessory to Agilia Infusion System as the stacking rack system intended to power and organize eight Agilia infusion pumps at the patient bedside. The Agilia Infusion System includes the Agilia Infusion Pump, which is a programmable electronic medical system dedicated to administering a pre-determined volume of an infusion product at a programmed rate, in combination with disposables and optional accessories. AGILIA LINK 8 US FRESENIUS KABI AG
3 04086000856713 Z076135 Z076135 Agilia Link 6 is an accessory to Agilia Infusion System as the stacking rack sys Agilia Link 6 is an accessory to Agilia Infusion System as the stacking rack system intended to power and organize six Agilia infusion pumps at the patient bedside. The Agilia Infusion System includes the Agilia Infusion Pump, which is a programmable electronic medical system dedicated to administering a pre-determined volume of an infusion product at a programmed rate, in combination with disposables and optional accessories. AGILIA LINK 6 US FRESENIUS KABI AG
4 04086000856669 Z074135 Z074135 Agilia Link 4 is an accessory to Agilia Infusion System as the stacking rack sys Agilia Link 4 is an accessory to Agilia Infusion System as the stacking rack system intended to power and organize four Agilia infusion pumps at the patient bedside. The Agilia Infusion System includes the Agilia Infusion Pump, which is a programmable electronic medical system dedicated to administering a pre-determined volume of an infusion product at a programmed rate, in combination with disposables and optional accessories. AGILIA LINK 4 US FRESENIUS KABI AG
5 04086000852074 Z073550 Z073550 The Agilia USB Cable is intended to connect the Agilia pumps from Fresenius Kabi The Agilia USB Cable is intended to connect the Agilia pumps from Fresenius Kabi to a computer with Fresenius Kabi maintenance or DERS software. AGILIA USB CABLE US FRESENIUS KABI AG
6 04052682058912 Z073607 Z073607 Agilia Duo is an accessory to Agilia Infusion System as the stacking rack system Agilia Duo is an accessory to Agilia Infusion System as the stacking rack system intended to power and organize two Agilia infusion pumps at the patient bedside. The Agilia Infusion System includes the Agilia Infusion Pump, which is a programmable electronic medical system dedicated to administering a pre-determined volume of an infusion product at a programmed rate, in combination with disposables and optional accessories. AGILIA DUO US FRESENIUS KABI AG
7 04046963418373 8713152 8713152 SpaceStation MRI SPACE B. BRAUN MEDICAL INC.
8 04046955083077 8713330 8713330 SPACE LOCKBOX FOR PERFUSOR SPACE PUMPS Perfusor® B. BRAUN MEDICAL INC.
9 00860008635402 B 10013795 EBS Elite Biomedical Solutions Dose Request Cord is a replacement for the BD Alaris Elite Biomedical Solutions Dose Request Cord is a replacement for the BD Alaris PCA Pump Model 8120 syringe infusion pump. Elite Biomedical Solutions does not manufacture the pump. The Dose Request Cord is an accessory for the pump and is available as a replacement part. The Dose Request Cord contains a handpiece with integral cable which plugs into the mating connector on the BD Alaris PCA Pump to allow the patient to request medication within the parameters entered into the syringe/infusion pump by the healthcare provider and the designed limits on the pumps.The Elite Biomedical Solutions Dose Request Cord has the same type of construction and technological characteristics as the predicate device, which is also a replacement bolus cable. Both the subject and predicate device are equivalent to the accessories supplied with the original pump. The Dose Request Cords are passive devices that contain no powered electronic components. They are powered by the mating equipment using low voltages to detect changes in the state of the push button. Shielding and insulation of these devices is substantially equivalent to the predicate device. Elite Biomedical Solutions ELITE BIOMEDICAL SOLUTIONS LLC
10 00815277022880 TA-UOM Thermal Angel Ultra Operations Module Curaplex BOUND TREE MEDICAL, LLC
11 00815277022873 TA-UEP Thermal Angel Ultra Emergency Pack, incl 2 IV Fluid Warmers, 2 Ext Sets, Battery Thermal Angel Ultra Emergency Pack, incl 2 IV Fluid Warmers, 2 Ext Sets, Battery, Charger, Cable Curaplex BOUND TREE MEDICAL, LLC
12 00815277022866 TA-SEP Thermal Angel Standard Emergency Pack, incl 4 IV Fluid Warmers, 4 Ext Sets, Batt Thermal Angel Standard Emergency Pack, incl 4 IV Fluid Warmers, 4 Ext Sets, Battery, Charger, Cable Curaplex BOUND TREE MEDICAL, LLC
13 00815277022859 TA-DEP Thermal Angel Disposable Emergency Pack Reload Kit, incl 4 IV Fluid Warmers, 4 Ext Sets Curaplex BOUND TREE MEDICAL, LLC
14 00815277022842 TA-200DEMOKIT KIT, TA-200 BLOOD WARMER NON-STERILE DEMO Curaplex BOUND TREE MEDICAL, LLC
15 00610586018636 21-5814-01 CADD SMITHS MEDICAL MD, INC.
16 00365702508101 06604765001 06604765001 ACCU-CHEK 360 INSULIN PUMP CONFIG SW US ACCU-CHEK 360 ROCHE DIAGNOSTICS OPERATIONS, INC.
17 B553WELLDOCRX120 v1.2 Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and thei Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes Rx provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Welldoc Diabetes Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value.Welldoc Diabetes Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions. Welldoc WELLDOC, INC.
18 B553WELLDOCRX110 v1.1 Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and thei Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes Rx provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Welldoc Diabetes Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value.Welldoc Diabetes Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions. Welldoc Rx WELLDOC, INC.
19 B553WELLDOCRX100 v1.0 Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and thei Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes Rx provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Welldoc Diabetes Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value.Welldoc Diabetes Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions. Welldoc Rx WELLDOC, INC.
20 B553WELLDOC120 v1.2 Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their p Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions. Welldoc WELLDOC, INC.
21 B553WELLDOC110 v1.1 Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their p Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions. Welldoc WELLDOC, INC.
22 B553WELLDOC100 v1.0 Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their p Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions. Welldoc WELLDOC, INC.
23 B553PULSERX100 v1.0 Pulse Rx by EHE Health (“Pulse”) is a Software as a Medical Device (SaMD) intend Pulse Rx by EHE Health (“Pulse”) is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older – who have type 1 or type 2 diabetes. Pulse Rx is intended to assist patients in managing their diabetes with guidance from their providers. Pulse Rx by EHE Health WELLDOC, INC.
24 B553PULSE100 v1.0 Pulse by EHE Health (“Pulse”) is a Software as a Medical Device (SaMD) intended Pulse by EHE Health (“Pulse”) is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older – who have type 1 or type 2 diabetes. Pulse is intended to assist patients in managing their diabetes with guidance from their providers. Pulse by EHE Health WELLDOC, INC.
25 B553PLUSRX120 v1.2 The Plus® Rx System is indicated for use by healthcare providers (HCPs) and thei The Plus® Rx System is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. The Plus® Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The Plus® RxSystem analyzes and reports blood glucose test results and supports medication adherence. In addition, the Plus® Rx System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Plus® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value.The Plus® Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. PlusRx WELLDOC, INC.
26 B553PLUSRX110 v1.1 The Plus® Rx System is indicated for use by healthcare providers (HCPs) and thei The Plus® Rx System is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. The Plus® Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The Plus® RxSystem analyzes and reports blood glucose test results and supports medication adherence. In addition, the Plus® Rx System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Plus® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value.The Plus® Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. PlusRx WELLDOC, INC.
27 B553PLUSRX100 v1.0 The Plus® Rx System is indicated for use by healthcare providers (HCPs) and thei The Plus® Rx System is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. The Plus® Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The Plus® RxSystem analyzes and reports blood glucose test results and supports medication adherence. In addition, the Plus® Rx System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Plus® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value.The Plus® Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. PlusRx WELLDOC, INC.
28 B553PLUS120 v1.2 The Plus System is indicated for use by healthcare providers (HCPs) and their pa The Plus System is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. The Plus System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The Plus System analyzes and reports blood glucose test results and supports medication adherence. In addition, the Plus System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or inprofessional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.The Plus System is not intended to replace the care provided by a licensed healthcare professional, includingprescriptions, diagnosis, or treatment. Plus WELLDOC, INC.
29 B553PLUS110 v1.1 The Plus System is indicated for use by healthcare providers (HCPs) and their pa The Plus System is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. The Plus System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The Plus System analyzes and reports blood glucose test results and supports medication adherence. In addition, the Plus System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or inprofessional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.The Plus System is not intended to replace the care provided by a licensed healthcare professional, includingprescriptions, diagnosis, or treatment. Plus WELLDOC, INC.
30 B553PLUS100 v1.0 The Plus System is indicated for use by healthcare providers (HCPs) and their pa The Plus System is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. The Plus System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The Plus System analyzes and reports blood glucose test results and supports medication adherence. In addition, the Plus System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or inprofessional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.The Plus System is not intended to replace the care provided by a licensed healthcare professional, includingprescriptions, diagnosis, or treatment. Plus WELLDOC, INC.
31 B553OTREVEALPLUSRX150 v1.5 OneTouch Reveal Plus Rx is a private-labeled version of BlueStarRx. DIABETES SU OneTouch Reveal Plus Rx is a private-labeled version of BlueStarRx. DIABETES SUPPORT, ANYTIME ANYWHERE™BlueStarRx is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 1 or type 2diabetes. BlueStarRx’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works withyou, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes fora healthier, happier you.BlueStarRx is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions whileproviding you with diabetes education and motivational support.COORDINATE YOUR CARE WITH YOUR DOCTORBefore your next diabetes check-up, you can use BlueStarRx to send your information to your doctor. This helps your healthcareprovider understand the challenges that you face between appointments so that during your office visit you can discuss atreatment plan that is just right for you.INDICATION FOR USEBlueStarRx is indicated for use by healthcare providers and their adult patients, aged 18 years and older, who have type 1 or type 2 diabetes.BlueStarRx provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, andeducational coaching messages to aid in diabetes self-management. BlueStarRx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. BlueStarRx is not intended to replace the care provided by alicensed healthcare professional, including prescriptions, diagnosis, or treatment.CONTRAINDICATIONS: Patients on insulin pumps, patients less than 18 years of age, and women who arepregnant.IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing anemergency, plea OneTouch Reveal Plus Rx WELLDOC, INC.
32 B553OTREVEALPLUSRX140 v1.4 OneTouch Reveal Plus Rx is a private-labeled version of BlueStarRx. DIABETES SU OneTouch Reveal Plus Rx is a private-labeled version of BlueStarRx. DIABETES SUPPORT, ANYTIME ANYWHERE™BlueStarRx is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 1 or type 2diabetes. BlueStarRx’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works withyou, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes fora healthier, happier you.BlueStarRx is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions whileproviding you with diabetes education and motivational support.COORDINATE YOUR CARE WITH YOUR DOCTORBefore your next diabetes check-up, you can use BlueStarRx to send your information to your doctor. This helps your healthcareprovider understand the challenges that you face between appointments so that during your office visit you can discuss atreatment plan that is just right for you.INDICATION FOR USEBlueStarRx is indicated for use by healthcare providers and their adult patients, aged 18 years and older, who have type 1 or type 2 diabetes.BlueStarRx provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, andeducational coaching messages to aid in diabetes self-management. BlueStarRx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. BlueStarRx is not intended to replace the care provided by alicensed healthcare professional, including prescriptions, diagnosis, or treatment.CONTRAINDICATIONS: Patients on insulin pumps, patients less than 18 years of age, and women who arepregnant.IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing anemergency, plea OneTouch Reveal Plus Rx WELLDOC, INC.
33 B553OTREVEALPLUSRX130 v1.3 OneTouch Reveal Plus Rx is a private-labeled version of BlueStarRx. DIABETES SU OneTouch Reveal Plus Rx is a private-labeled version of BlueStarRx. DIABETES SUPPORT, ANYTIME ANYWHERE™BlueStarRx is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 2diabetes. BlueStarRx’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works withyou, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes fora healthier, happier you.BlueStarRx is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions whileproviding you with diabetes education and motivational support.COORDINATE YOUR CARE WITH YOUR DOCTORBefore your next diabetes check-up, you can use BlueStarRx to send your information to your doctor. This helps your healthcareprovider understand the challenges that you face between appointments so that during your office visit you can discuss atreatment plan that is just right for you.INDICATION FOR USEBlueStarRx is indicated for use by healthcare providers and their adult patients, aged 21 years and older, who have type 2 diabetes.BlueStarRx provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, andeducational coaching messages to aid in diabetes self-management. BlueStarRx is not intended to replace the care provided by alicensed healthcare professional, including prescriptions, diagnosis, or treatment.CONTRAINDICATIONS: Type 1 diabetes, patients on insulin pumps, patients less than 21 years of age, and women who arepregnant.IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing anemergency, please dial 911.Caution: Federal law restricts this device to sale by or on the order of a physician.For more information visit www.bluestardiabetes.com OneTouch Reveal Plus Rx WELLDOC, INC.
34 B553OTREVEALPLUSRX120 v1.2 OneTouch Reveal Plus Rx is a private-labeled version of BlueStarRx. DIABETES SU OneTouch Reveal Plus Rx is a private-labeled version of BlueStarRx. DIABETES SUPPORT, ANYTIME ANYWHERE™BlueStarRx is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 2diabetes. BlueStarRx’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works withyou, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes fora healthier, happier you.BlueStarRx is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions whileproviding you with diabetes education and motivational support.COORDINATE YOUR CARE WITH YOUR DOCTORBefore your next diabetes check-up, you can use BlueStarRx to send your information to your doctor. This helps your healthcareprovider understand the challenges that you face between appointments so that during your office visit you can discuss atreatment plan that is just right for you.INDICATION FOR USEBlueStarRx is indicated for use by healthcare providers and their adult patients, aged 21 years and older, who have type 2 diabetes.BlueStarRx provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, andeducational coaching messages to aid in diabetes self-management. BlueStarRx is not intended to replace the care provided by alicensed healthcare professional, including prescriptions, diagnosis, or treatment.CONTRAINDICATIONS: Type 1 diabetes, patients on insulin pumps, patients less than 21 years of age, and women who arepregnant.IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing anemergency, please dial 911.Caution: Federal law restricts this device to sale by or on the order of a physician.For more information visit www.bluestardiabetes.com OneTouch Reveal Plus Rx WELLDOC, INC.
35 B553OTREVEALPLUS150 v1.5 OneTouch Reveal Plus is a private-labeled version of BlueStar. DIABETES SUPPORT OneTouch Reveal Plus is a private-labeled version of BlueStar. DIABETES SUPPORT, ANYTIME ANYWHERE™BlueStar is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 1 or type 2diabetes. BlueStar’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works withyou, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes fora healthier, happier you.BlueStar is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions whileproviding you with diabetes education and motivational support.COORDINATE YOUR CARE WITH YOUR DOCTORBefore your next diabetes check-up, you can use BlueStar to send your information to your doctor. This helps your healthcareprovider understand the challenges that you face between appointments so that during your office visit you can discuss atreatment plan that is just right for you.INDICATION FOR USEBlueStar is indicated for use by healthcare providers and their adult patients, aged 18 years and older, who have type 1 or type 2 diabetes.BlueStar provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, andeducational coaching messages to aid in diabetes self-management. BlueStar is not intended to replace the care provided by alicensed healthcare professional, including prescriptions, diagnosis, or treatment.CONTRAINDICATIONS: Patients on insulin pumps, patients less than 18 years of age, and women who arepregnant.IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing anemergency, please dial 911.Caution: Federal law restricts this device to sale by or on the order of a physician.For more information visit www.bluestardiabetes.com OneTouch Reveal Plus WELLDOC, INC.
36 B553OTREVEALPLUS140 v1.4 OneTouch Reveal Plus is a private-labeled version of BlueStar. DIABETES SUPPORT OneTouch Reveal Plus is a private-labeled version of BlueStar. DIABETES SUPPORT, ANYTIME ANYWHERE™BlueStar is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 1 or type 2diabetes. BlueStar’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works withyou, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes fora healthier, happier you.BlueStar is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions whileproviding you with diabetes education and motivational support.COORDINATE YOUR CARE WITH YOUR DOCTORBefore your next diabetes check-up, you can use BlueStar to send your information to your doctor. This helps your healthcareprovider understand the challenges that you face between appointments so that during your office visit you can discuss atreatment plan that is just right for you.INDICATION FOR USEBlueStar is indicated for use by healthcare providers and their adult patients, aged 18 years and older, who have type 1 or type 2 diabetes.BlueStar provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, andeducational coaching messages to aid in diabetes self-management. BlueStar is not intended to replace the care provided by alicensed healthcare professional, including prescriptions, diagnosis, or treatment.CONTRAINDICATIONS: Patients on insulin pumps, patients less than 18 years of age, and women who arepregnant.IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing anemergency, please dial 911.Caution: Federal law restricts this device to sale by or on the order of a physician.For more information visit www.bluestardiabetes.com OneTouch Reveal Plus WELLDOC, INC.
37 B553OTREVEALPLUS130 v1.3 OneTouch Reveal Plus is a private-labeled version of BlueStarRx. DIABETES SUPPO OneTouch Reveal Plus is a private-labeled version of BlueStarRx. DIABETES SUPPORT, ANYTIME ANYWHERE™BlueStar is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 2diabetes. BlueStar’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works withyou, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes fora healthier, happier you.BlueStar is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions whileproviding you with diabetes education and motivational support.COORDINATE YOUR CARE WITH YOUR DOCTORBefore your next diabetes check-up, you can use BlueStar to send your information to your doctor. This helps your healthcareprovider understand the challenges that you face between appointments so that during your office visit you can discuss atreatment plan that is just right for you.INDICATION FOR USEBlueStar is indicated for use by healthcare providers and their adult patients, aged 21 years and older, who have type 2 diabetes.BlueStar provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, andeducational coaching messages to aid in diabetes self-management. BlueStar is not intended to replace the care provided by alicensed healthcare professional, including prescriptions, diagnosis, or treatment.CONTRAINDICATIONS: Type 1 diabetes, patients on insulin pumps, patients less than 21 years of age, and women who arepregnant.IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing anemergency, please dial 911.Caution: Federal law restricts this device to sale by or on the order of a physician.For more information visit www.bluestardiabetes.com OneTouch Reveal Plus WELLDOC, INC.
38 B553OTREVEALPLUS120 v1.2 OneTouch Reveal Plus is a private-labeled version of BlueStarRx. DIABETES SUPPO OneTouch Reveal Plus is a private-labeled version of BlueStarRx. DIABETES SUPPORT, ANYTIME ANYWHERE™BlueStar is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 2diabetes. BlueStar’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works withyou, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes fora healthier, happier you.BlueStar is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions whileproviding you with diabetes education and motivational support.COORDINATE YOUR CARE WITH YOUR DOCTORBefore your next diabetes check-up, you can use BlueStar to send your information to your doctor. This helps your healthcareprovider understand the challenges that you face between appointments so that during your office visit you can discuss atreatment plan that is just right for you.INDICATION FOR USEBlueStar is indicated for use by healthcare providers and their adult patients, aged 21 years and older, who have type 2 diabetes.BlueStar provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, andeducational coaching messages to aid in diabetes self-management. BlueStar is not intended to replace the care provided by alicensed healthcare professional, including prescriptions, diagnosis, or treatment.CONTRAINDICATIONS: Type 1 diabetes, patients on insulin pumps, patients less than 21 years of age, and women who arepregnant.IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing anemergency, please dial 911.Caution: Federal law restricts this device to sale by or on the order of a physician.For more information visit www.bluestardiabetes.com OneTouch Reveal Plus WELLDOC, INC.
39 B553HLTHOPTIMIZERX130 v1.3 Health Optimizer® Rx is indicated for use by healthcare providers (HCPs) and the Health Optimizer® Rx is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. Health Optimizer Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Health Optimizer Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer Rx provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. The following Health Optimizer Rx insulin management feature is for prescription use only: For bolus insulin users with type 1 or type 2 diabetes, Health Optimizer Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. Health Optimizer Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. Health Optimizer Rx WELLDOC, INC.
40 B553HLTHOPTIMIZERX120 v1.2 Health Optimizer® Rx is indicated for use by healthcare providers (HCPs) and the Health Optimizer® Rx is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. Health Optimizer Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Health Optimizer Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer Rx provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. The following Health Optimizer Rx insulin management feature is for prescription use only: For bolus insulin users with type 1 or type 2 diabetes, Health Optimizer Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. Health Optimizer Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. Health Optimizer Rx WELLDOC, INC.
41 B553HLTHOPTIMIZERX110 v1.1 Health Optimizer® Rx is indicated for use by healthcare providers (HCPs) and the Health Optimizer® Rx is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. Health Optimizer Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Health Optimizer Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer Rx provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. The following Health Optimizer Rx insulin management feature is for prescription use only: For bolus insulin users with type 1 or type 2 diabetes, Health Optimizer Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. Health Optimizer Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. Health Optimizer Rx WELLDOC, INC.
42 B553HLTHOPTIMIZERRX100 v1.0 Health Optimizer® is indicated for use by healthcare providers (HCPs) and their Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. Health Optimizer is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Health Optimizer analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. The following Health Optimizer insulin management feature is for prescription use only: For bolus insulin users with type 1 or type 2 diabetes, Health Optimizer includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. Health Optimizer is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. Health Optimizer WELLDOC, INC.
43 B553HLTHOPTIMIZER130 v1.3 Health Optimizer® is indicated for use by healthcare providers (HCPs) and their Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Health Optimizer is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Health Optimizer analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Health Optimizer WELLDOC, INC.
44 B553HLTHOPTIMIZER120 1.2 Health Optimizer® is indicated for use by healthcare providers (HCPs) and their Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Health Optimizer is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Health Optimizer analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Health Optimizer WELLDOC, INC.
45 B553HLTHOPTIMIZER110 v1.1 Health Optimizer® is indicated for use by healthcare providers (HCPs) and their Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. Health Optimizer is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Health Optimizer analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Health Optimizer is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. Health Optimizer WELLDOC, INC.
46 B553HLTHOPTIMIZER100 v1.0 Health Optimizer® is indicated for use by healthcare providers (HCPs) and their Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. Health Optimizer is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Health Optimizer analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Health Optimizer is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. Health Optimizer WELLDOC, INC.
47 B553BYRAMCONNECTRX100 v1.0 ByramConnect™ Rx is indicated for use by healthcare providers (HCPs) and their p ByramConnect™ Rx is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. ByramConnect Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. ByramConnect Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, ByramConnect Rx provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. ByramConnect Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value.ByramConnect Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.ByramConnect Rx is not indicated for people with gestational diabetes or who use an insulin pump.IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing anemergency, please dial 911. ByramConnect Rx WELLDOC, INC.
48 B553BYRAMCONNECT100 v1.0 ByramConnect™ is indicated for use by healthcare providers (HCPs) and their pati ByramConnect™ is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. ByramConnect is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. ByramConnect analyzes and reports blood glucose test results and supports medication adherence. In addition, ByramConnect provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. ByramConnect is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.ByramConnect is not indicated for people with gestational diabetes or who use an insulin pump.IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing anemergency, please dial 911. ByramConnect WELLDOC, INC.
49 B553BLUESTARRX620 v6.2 DIABETES SUPPORT, ANYTIME ANYWHERE™BlueStarRx is not a pill or a shot — it's a c DIABETES SUPPORT, ANYTIME ANYWHERE™BlueStarRx is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 1 or type 2diabetes. BlueStarRx’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works withyou, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes fora healthier, happier you.BlueStarRx is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions whileproviding you with diabetes education and motivational support.COORDINATE YOUR CARE WITH YOUR DOCTORBefore your next diabetes check-up, you can use BlueStarRx to send your information to your doctor. This helps your healthcareprovider understand the challenges that you face between appointments so that during your office visit you can discuss atreatment plan that is just right for you.INDICATION FOR USEBlueStarRx is indicated for use by healthcare providers and their adult patients, aged 18 years and older, who have type 1 or type 2 diabetes.BlueStarRx provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, andeducational coaching messages to aid in diabetes self-management. BlueStarRx is not intended to replace the care provided by alicensed healthcare professional, including prescriptions, diagnosis, or treatment.CONTRAINDICATIONS: Patients on insulin pumps, patients less than 18 years of age, and women who arepregnant.IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing anemergency, please dial 911.Caution: Federal law restricts this device to sale by or on the order of a physician.For more information visit www.bluestardiabetes.com BlueStarRx WELLDOC, INC.
50 B553BLUESTARRX610 v6.1 DIABETES SUPPORT, ANYTIME ANYWHERE™BlueStarRx is not a pill or a shot — it's a c DIABETES SUPPORT, ANYTIME ANYWHERE™BlueStarRx is not a pill or a shot — it's a completely new kind of approach to support you and help you manage your type 1 or type 2diabetes. BlueStarRx’s real-time coaching fits into your daily life helping you stay on track with your diabetes self-care. It works withyou, struggles with you, achieves with you, and celebrates with you. It can help make living with diabetes easier which makes fora healthier, happier you.BlueStarRx is accessible from your mobile phone, tablet, or computer, and supports your healthcare provider’s instructions whileproviding you with diabetes education and motivational support.COORDINATE YOUR CARE WITH YOUR DOCTORBefore your next diabetes check-up, you can use BlueStarRx to send your information to your doctor. This helps your healthcareprovider understand the challenges that you face between appointments so that during your office visit you can discuss atreatment plan that is just right for you.INDICATION FOR USEBlueStarRx is indicated for use by healthcare providers and their adult patients, aged 18 years and older, who have type 1 or type 2 diabetes.BlueStarRx provides secure capture, storage, and transmission of diabetes data, as well as, motivational, behavioral, andeducational coaching messages to aid in diabetes self-management. BlueStarRx is not intended to replace the care provided by alicensed healthcare professional, including prescriptions, diagnosis, or treatment.CONTRAINDICATIONS: Patients on insulin pumps, patients less than 18 years of age, and women who arepregnant.IMPORTANT SAFETY INFORMATION: For medical questions, please contact your healthcare provider. If you are experiencing anemergency, please dial 911.Caution: Federal law restricts this device to sale by or on the order of a physician.For more information visit www.bluestardiabetes.com BlueStarRx WELLDOC, INC.