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ByramConnect

FDA UDI

Class II (US FDA UDI)

by Welldoc

Identity

Trade Name
ByramConnect FDA UDI
Generic Name
Home pharmaceutical management support software FDA UDI
Device Name
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 an emergency, please dial 911. FDA UDI
Model / Reference
v1.0 FDA UDI
Description
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 an emergency, please dial 911. FDA UDI

Identifiers

Primary DI / UDI-DI
B553BYRAMCONNECT100 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 by Welldoc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Home pharmaceutical management support software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Welldoc

Sources (1)

  • FDA UDI 3e490ac5-619f-4ee3-aa66-fbf365e64a9b 34 fields · synced May 29, 2026