Identity
- Trade Name
- ByramConnect Rx FDA UDI
- Generic Name
- Home pharmaceutical management support software FDA UDI
- Device Name
- 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 an emergency, please dial 911. FDA UDI
- Model / Reference
- v1.0 FDA UDI
- Description
- 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 an emergency, please dial 911. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B553BYRAMCONNECTRX100 FDA UDI
- FDA Product Code
- MRZ FDA UDI
- GMDN Term
- Home pharmaceutical management support software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Home pharmaceutical management support software
ByramConnect Rx by Welldoc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Welldoc
Sources (1)
- FDA UDI 055fa139-7a55-4879-90b8-2001afcae4c0 34 fields · synced May 29, 2026