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Welldoc

FDA UDI

Class II (US FDA UDI)

by Welldoc

Identity

Trade Name
Welldoc FDA UDI
Generic Name
Home pharmaceutical management support software FDA UDI
Device Name
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. FDA UDI
Model / Reference
v1.3 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
B553WELLDOCRX130 FDA UDI
510(k) Number
K203434 FDA UDI
FDA Product Code
NDC FDA UDI
GMDN Term
Home pharmaceutical management support software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1890 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

Yes

FDA UDI

Over-the-Counter

No

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

Welldoc by Welldoc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Home pharmaceutical management support software.

Cleared under the same submission

K203434 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Welldoc

Sources (1)

  • FDA UDI 90b3b2d0-3650-464c-b870-c6a3f1fec314 35 fields · synced Jun 1, 2026