Welldoc App for Diabetes in Pregnancy and Insulin Pump Users

GUDID B553202057OTC0

The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump. The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates electronic reports intended for a healthcare provider. The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies. The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.

WELLDOC, INC.

Self-care monitoring/reporting software

• Primary Device ID: B553202057OTC0
• NIH Device Record Key: 0af2a8ae-0d91-471d-a4f8-8cbb544058a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Welldoc App for Diabetes in Pregnancy and Insulin Pump Users
• Version Model Number: v2.X
• Company DUNS: 021217115
• Company Name: WELLDOC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com
• Phone: 1-888-611-4794
• Email: connect@welldoc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B553202057OTC0 [Primary]

FDA Product Code

• PHV: Continuous Glucose Monitor Retrospective Data Analysis Software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-06
• Device Publish Date: 2024-12-27

On-Brand Devices [Welldoc App for Diabetes in Pregnancy and Insulin Pump Users]

• B553202058OTC0: The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as
• B553202057OTC0: The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as