Other products from "BOUND TREE MEDICAL, LLC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00815277026727 38006 Curaplex Endotracheal Tube with Stylette, 5.0mm, Uncuffed 10ea/bx 10bx/cs BTR Tube, tracheal (w/wo connector) 2 Curaplex
2 00815277026697 38005 Curaplex Endotracheal Tube with Stylette, 4.5mm, Uncuffed 10ea/bx 10bx/cs BTR Tube, tracheal (w/wo connector) Curaplex
3 00817617022567 2113-10335 Curaplex Select Endotracheal Tube with Stylette, 3.5mm, Uncuffed 10ea/bx 10bx/cs BTR Tube, tracheal (w/wo connector) Curaplex
4 00817617022550 2113-10330 Curaplex Select Endotracheal Tube with Stylette, 3.0mm, Uncuffed 10ea/bx 10bx/cs BTR Tube, tracheal (w/wo connector) Curaplex
5 00817617022543 2113-10290 Curaplex Select Endotracheal Tube with Stylette, 9.0mm, Cuffed 10ea/bx 10bx/cs BTR Tube, tracheal (w/wo connector) 2 Curaplex
6 00817617022536 2113-10285 Curaplex Select Endotracheal Tube with Stylette, 8.5mm, Cuffed 10ea/bx 10bx/cs BTR Tube, tracheal (w/wo connector) 2 Curaplex
7 00817617022529 2113-10280 Curaplex Select Endotracheal Tube with Stylette, 8.0mm, Cuffed 10ea/bx 10bx/cs BTR Tube, tracheal (w/wo connector) 2 Curaplex
8 00817617022512 2113-10275 Curaplex Select Endotracheal Tube with Stylette, 7.5mm, Cuffed 10ea/bx 10bx/cs BTR Tube, tracheal (w/wo connector) Curaplex
9 00817617022505 2113-10270 Curaplex Select Endotracheal Tube with Stylette, 7.0mm, Cuffed 10ea/bx 10bx/cs BTR Tube, tracheal (w/wo connector) Curaplex
10 00817617022499 2113-10265 Curaplex Select Endotracheal Tube with Stylette, 6.5mm, Cuffed 10ea/bx 10bx/cs BTR Tube, tracheal (w/wo connector) Curaplex
11 00817617022482 2113-10255 Curaplex Select Endotracheal Tube with Stylette, 5.5mm, Cuffed 10ea/bx 10bx/cs BTR Tube, tracheal (w/wo connector) Curaplex
12 00817617022475 2113-10250 Curaplex Select Endotracheal Tube with Stylette, 5.0mm, Cuffed 10ea/bx 10bx/cs BTR Tube, tracheal (w/wo connector) 2 Curaplex
13 00817617022468 2113-10245 Curaplex Select Endotracheal Tube with Stylette, 4.5mm, Cuffed 10ea/bx 10bx/cs BTR Tube, tracheal (w/wo connector) 2 Curaplex
14 00817617022451 2113-10235 Curaplex Select Endotracheal Tube with Stylette, 3.5mm, Cuffed 10ea/bx 10bx/cs BTR Tube, tracheal (w/wo connector) Curaplex
15 00817617022444 1612-84245 IV Catheter, ClearSafe Comfort, 20 ga x 1 in, Safety 50ea/bx 4bx/cs FOZ Catheter,intravascular,therapeutic,short-term less than 30 days Curaplex
16 00817617022437 1612-84240 IV Catheter, ClearSafe Comfort, 20 ga x 1 1/4 in, Safety 50ea/bx 4bx/cs FOZ Catheter,intravascular,therapeutic,short-term less than 30 days 2 Curaplex
17 00817617022420 1612-84230 IV Catheter, ClearSafe Comfort, 18 ga x 1 1/4 in, Safety 50ea/bx 4bx/cs FOZ Catheter,intravascular,therapeutic,short-term less than 30 days 2 Curaplex
18 00817617022413 1612-84220 IV Catheter, ClearSafe Comfort, 16 ga x 1 1/4 in, Safety 50ea/bx 4bx/cs FOZ Catheter,intravascular,therapeutic,short-term less than 30 days Curaplex
19 00817617022406 1612-84160 IV Catheter, ClearSafe, 24 ga x 3/4 in, Safety 50ea/bx 4bx/cs FOZ Catheter,intravascular,therapeutic,short-term less than 30 days 2 Curaplex
20 00817617022390 1612-84150 IV Catheter, ClearSafe, 22 ga x 1 in, Safety 50ea/bx 4bx/cs FOZ Catheter,intravascular,therapeutic,short-term less than 30 days 2 Curaplex
21 00815277027687 660223 BASIC TRAUMA KIT - US EMBASSY HEB,GAR,NBW,MMK,BTM,FMF,DXQ,MHC,DQA,POQ,FRO,FOZ TAMPON, MENSTRUAL, UNSCENTED,Suture, nonabsorbable, synthetic, polyamide,SYSTEM, TAMPON, MENSTRUAL, UNSCENTED,Suture, nonabsorbable, synthetic, polyamide,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Container, sharps,Ventilator, emergency, manual (resuscitator),Syringe, piston,blood pressure cuff,PORT, INTRAOSSEOUS, IMPLANTED,Oximeter,Blood transfusion kit,Dressing, wound, drug,Catheter,intravascular,therapeutic,short-term less than 30 days 2 Curaplex
22 00817617022383 1612-84145 IV Catheter, ClearSafe, 20 ga x 1 in, Safety 50ea/bx 4bx/cs FOZ Catheter,intravascular,therapeutic,short-term less than 30 days 2 Curaplex
23 00815277027670 660205 Curaplex 8.5 Intubation Kit OGK Orotrachael intubation guide kit 2 Curaplex
24 00817617022376 1612-84140 IV Catheter, ClearSafe, 20 ga x 1 1/4 in, Safety 50ea/bx 4bx/cs FOZ Catheter,intravascular,therapeutic,short-term less than 30 days Curaplex
25 00817617022369 1612-84130 IV Catheter, ClearSafe, 18 ga x 1 1/4 in, Safety 50ea/bx 4bx/cs FOZ Catheter,intravascular,therapeutic,short-term less than 30 days 2 Curaplex
26 00817617022352 14762MS Curaplex Nasogastric Tube, 18Fr 280ea/cs KNT TUBES, GASTROINTESTINAL (AND ACCESSORIES) Curaplex
27 00817617022345 14761 Curaplex Nasogastric Tube, 16Fr 280ea/cs KNT TUBES, GASTROINTESTINAL (AND ACCESSORIES) Curaplex
28 00817617022338 14759 Curaplex Nasogastric Tube, 14Fr 280ea/cs KNT TUBES, GASTROINTESTINAL (AND ACCESSORIES) Curaplex
29 00817617022321 14758MS Curaplex Nasogastric Tube, 12Fr 280ea/cs KNT TUBES, GASTROINTESTINAL (AND ACCESSORIES) Curaplex
30 00817617022314 14757MS Curaplex Nasogastric Tube, 10Fr 280ea/cs KNT TUBES, GASTROINTESTINAL (AND ACCESSORIES) Curaplex
31 00817617022307 14756MS Curaplex Nasogastric Tube, 8Fr 280ea/cs KNT TUBES, GASTROINTESTINAL (AND ACCESSORIES) Curaplex
32 00815277027663 660204 Curaplex 8.0 Intubation Kit OGK Orotrachael intubation guide kit 2 Curaplex
33 00817617022291 12992 Curaplex Infra-Red Ear Thermometer 20ea/cs FLL Thermometer, electronic, clinical 2 Curaplex
34 00817617021386 8600-01181 *Custom* City of Joliet Chest Decompression Kit FOZ,KDQ Catheter,intravascular,therapeutic,short-term less than 30 days,BOTTLE, COLLECTION, VACUUM 2 Curaplex
35 00817617021379 8600-01112 *Custom* NY IFAK OHO First aid kit without drug 1 Curaplex
36 00817617021362 670006-KIT Kit, DHS IFAK- Oakland OHO First aid kit without drug 1 Curaplex
37 00817617021355 662157 Curaplex Officer Vehicle Trauma Kit OHO First aid kit without drug 1 Curaplex
38 00815277027465 2525-36703 KIT, RAPID RESPONSE AIR - RRAK OGI,BZT,CCK,CAN,DQA,OGH,LNZ,KGB Nasal endotracheal tube holder kit,STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL COND Nasal endotracheal tube holder kit,STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS,ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE,REGULATOR, PRESSURE, GAS CYLINDER,Oximeter,Laryngoscope kit,Changer, tube, endotracheal,MASK, OXYGEN, NON-REBREATHING 1 Curaplex
39 00815277021036 4267C Kit Contents Only For Curaplex Deluxe Responder Kit 684267C DXQ,CBP blood pressure cuff,Valve, non-rebreathing 2 Curaplex
40 00815277021029 382000RC Curaplex Kit Responder Red CAN,DXQ,CBP REGULATOR, PRESSURE, GAS CYLINDER,blood pressure cuff,Valve, non-rebreathing 1 Curaplex
41 00815277027052 38017 Curaplex Endotracheal Tube with Stylette, 8.0mm, Cuffed 10ea/bx 10bx/cs BTR Tube, tracheal (w/wo connector) Curaplex
42 00815277021012 382000OC Curaplex Kit Responder Orange CAN,CBP,DXQ REGULATOR, PRESSURE, GAS CYLINDER,Valve, non-rebreathing,blood pressure cuff 1 Curaplex
43 00815277027021 38016 Curaplex Endotracheal Tube with Stylette, 7.5mm, Cuffed 10ea/bx 10bx/cs BTR Tube, tracheal (w/wo connector) Curaplex
44 00815277026994 38015 Curaplex Endotracheal Tube with Stylette, 7.0mm, Cuffed 10ea/bx 10bx/cs BTR Tube, tracheal (w/wo connector) 2 Curaplex
45 00815277021005 382000GC Curaplex Kit Responder Green CAN,DXQ,CBP REGULATOR, PRESSURE, GAS CYLINDER,blood pressure cuff,Valve, non-rebreathing 1 Curaplex
46 00815277026963 38014 Curaplex Endotracheal Tube with Stylette, 6.5mm, Cuffed 10ea/bx 10bx/cs BTR Tube, tracheal (w/wo connector) 2 Curaplex
47 00815277026932 38013 Curaplex Endotracheal Tube with Stylette, 6.0mm, Cuffed 10ea/bx 10bx/cs BTR Tube, tracheal (w/wo connector) Curaplex
48 00815277025720 36045 Curaplex CPR Pocketmask w/O2 inlet 100ea/cs CBP Valve, non-rebreathing 2 Curaplex
49 00815277020992 382000BC Curaplex Kit Responder Blue CBP,CAN,DXQ Valve, non-rebreathing,REGULATOR, PRESSURE, GAS CYLINDER,blood pressure cuff 1 Curaplex
50 00815277026901 38012 Curaplex Endotracheal Tube with Stylette, 5.5mm, Cuffed 10ea/bx 10bx/cs BTR Tube, tracheal (w/wo connector) Curaplex
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.