Welldoc App for Diabetes in Pregnancy and Insulin Pump Users

GUDID B553202258OTC0

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 IDB553202258OTC0
NIH Device Record Key04a809ca-52ee-4032-bb13-0b7429f31fd1
Commercial Distribution StatusIn Commercial Distribution
Brand NameWelldoc App for Diabetes in Pregnancy and Insulin Pump Users
Version Model Number3.X
Company DUNS021217115
Company NameWELLDOC, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB553202258OTC0 [Primary]

FDA Product Code

PJTContinuous Glucose Monitor Secondary Display

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-06
Device Publish Date2025-05-29

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

B553202058OTC0The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as
B553202057OTC0The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as
B553202258OTC0The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as
B553202257OTC0The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as
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