Other products from "SMITHS MEDICAL MD, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 10610586032769 21-4482-24 LJT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR 2 Deltec
2 10610586032738 21-4470-24 LJT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR 2 Deltec
3 10610586032677 21-4452-24 LJT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR 2 Deltec
4 15019517130928 67-2586-0100-01 67-2586-0100-01 is an electronic file. There is no packaging. FRN,MRZ Pump, infusion,ACCESSORIES, PUMP, INFUSION 2 Medfusion
5 15019517086256 24-2231-01 CAZ Anesthesia conduction kit 2 Portex
6 15019517086225 24-2228-01 CAZ Anesthesia conduction kit 2 Portex
7 15019517086201 24-2227-01 CAZ Anesthesia conduction kit 2 Portex
8 15019517086188 24-2226-01 CAZ Anesthesia conduction kit 2 Portex
9 15019517086171 24-2225-01 CAZ Anesthesia conduction kit 2 Portex
10 15019517086157 24-2224-01 CAZ Anesthesia conduction kit 2 Portex
11 15019517086126 24-2223-01 CAZ Anesthesia conduction kit 2 Portex
12 15019517085884 24-2220-01 CAZ Anesthesia conduction kit 2 Portex
13 15019517085853 24-2219-01 CAZ Anesthesia conduction kit 2 Portex
14 15019517085846 24-2218-01 CAZ Anesthesia conduction kit 2 Portex
15 15019517085839 24-2217-01 CAZ Anesthesia conduction kit 2 Portex
16 15019517085822 24-2216-01 CAZ Anesthesia conduction kit 2 Portex
17 15019517085815 24-2215-01 CAZ Anesthesia conduction kit 2 Portex
18 15019517085808 24-2214-01 CAZ Anesthesia conduction kit 2 Portex
19 15019517085457 24-2210-01 CAZ Anesthesia conduction kit 2 Portex
20 15019517081282 2193 21-2193-0402-25 FPA,MEA,MRZ Set, administration, intravascular,Pump, infusion, pca,ACCESSORIES, PUMP, INFUSION 2 PharmGuard
21 15019517081275 2194 21-2194-0402-25 MEA,FPA,MRZ Pump, infusion, pca,Set, administration, intravascular,ACCESSORIES, PUMP, INFUSION 2 PharmGuard
22 15019517074789 24-2221-01 CAZ Anesthesia conduction kit Portex
23 15019517046229 101/506/050 JOH Tube tracheostomy and tube cuff 2 Portex
24 15019517046212 101/506/045 JOH Tube tracheostomy and tube cuff Portex
25 15019517046205 101/506/040 JOH Tube tracheostomy and tube cuff Portex
26 15019517046199 101/506/035 JOH Tube tracheostomy and tube cuff Portex
27 15019315056789 100/126/040 BTR Tube, tracheal (w/wo connector) 2 Portex
28 15019315056772 100/126/035 BTR Tube, tracheal (w/wo connector) 2 Portex
29 15019315056765 100/126/030 BTR Tube, tracheal (w/wo connector) 2 Portex
30 15019315054075 100/166/065 BTR Tube, tracheal (w/wo connector) Portex
31 15019315054068 100/166/060 BTR Tube, tracheal (w/wo connector) 2 Portex
32 15019315019951 100/127/095 BTR Tube, tracheal (w/wo connector) Portex
33 15019315019937 100/127/090 BTR Tube, tracheal (w/wo connector) 2 Portex
34 15019315019920 100/127/085 BTR Tube, tracheal (w/wo connector) Portex
35 15019315019906 100/127/075 BTR Tube, tracheal (w/wo connector) Portex
36 15019315019883 100/127/065 BTR Tube, tracheal (w/wo connector) 2 Portex
37 15019315019876 100/127/060 BTR Tube, tracheal (w/wo connector) Portex
38 10610586043574 4000-0105-78 MRZ,FRN ACCESSORIES, PUMP, INFUSION,Pump, infusion 2 Medfusion
39 10610586043567 4000-0105-51 MRZ,FRN ACCESSORIES, PUMP, INFUSION,Pump, infusion 2 Medfusion
40 10610586041525 22-4095-0200-51 MRZ,FRN ACCESSORIES, PUMP, INFUSION,Pump, infusion 2 Medfusion
41 10610586041259 3500-0600-00 MRZ,FRN ACCESSORIES, PUMP, INFUSION,Pump, infusion 2 Medfusion
42 10610586041242 3500-0600-01 FRN,MRZ Pump, infusion,ACCESSORIES, PUMP, INFUSION 2 Medfusion
43 10610586040962 22-4075-0300-51 MRZ,FRN ACCESSORIES, PUMP, INFUSION,Pump, infusion 2 Medfusion
44 10610586040818 4000-0101-51 FRN,MRZ Pump, infusion,ACCESSORIES, PUMP, INFUSION 2 Medfusion
45 10610586040092 22-4095-0101-51 FRN,MRZ Pump, infusion,ACCESSORIES, PUMP, INFUSION 2 Medfusion
46 10610586039812 22-4075-0201-51 FRN,MRZ Pump, infusion,ACCESSORIES, PUMP, INFUSION 2 Medfusion
47 00610586032595 MFCC1 FRN Pump, infusion 2 Medfusion
48 00610586032335 22-3510-51 FRN Pump, infusion 2 Medfusion
49 35019517053924 1102P CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE BCI
50 30610586028414 21-7232-24 FPA Set, administration, intravascular Cleo
Other products with the same Product Code "MRZ"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 08809220581045 ⅡS Kits DANA Diabecare ⅡS is external programmable syringe infusion pump used for the su DANA Diabecare ⅡS is external programmable syringe infusion pump used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. DANA Diabecare SOOIL DEVELOPMENT CO.,LTD
2 08809220580765 DANA 3cc Syringe DANA 3cc Syringe is an insulin reservoir for using insulin pump. It is installed DANA 3cc Syringe is an insulin reservoir for using insulin pump. It is installed into the SOOIL's insulin pump and connected to an infusion set in order to deliver insulin to the patients. DANA 3cc Syringe SOOIL DEVELOPMENT CO.,LTD
3 G002RG30 RG3 RG3 SHIFENG MEDICAL TECHNOLOGY CO.,LTD.
4 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
5 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
6 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
7 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
8 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
9 04046963418373 8713152 8713152 SpaceStation MRI SPACE B. BRAUN MEDICAL INC.
10 04046955083077 8713330 8713330 SPACE LOCKBOX FOR PERFUSOR SPACE PUMPS Perfusor® B. BRAUN MEDICAL INC.
11 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
12 00815277022880 TA-UOM Thermal Angel Ultra Operations Module Curaplex BOUND TREE MEDICAL, LLC
13 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
14 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
15 00815277022859 TA-DEP Thermal Angel Disposable Emergency Pack Reload Kit, incl 4 IV Fluid Warmers, 4 Ext Sets Curaplex BOUND TREE MEDICAL, LLC
16 00815277022842 TA-200DEMOKIT KIT, TA-200 BLOOD WARMER NON-STERILE DEMO Curaplex BOUND TREE MEDICAL, LLC
17 00610586018636 21-5814-01 CADD SMITHS MEDICAL MD, INC.
18 00365702508101 06604765001 06604765001 ACCU-CHEK 360 INSULIN PUMP CONFIG SW US ACCU-CHEK 360 ROCHE DIAGNOSTICS OPERATIONS, INC.
19 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.
20 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.
21 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.
22 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.
23 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.
24 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.
25 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.
26 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.
27 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.
28 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.
29 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.
30 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.
31 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.
32 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.
33 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.
34 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.
35 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.
36 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.
37 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.
38 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.
39 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.
40 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.
41 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.
42 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.
43 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.
44 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.
45 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.
46 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.
47 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.
48 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.
49 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.
50 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.