AccessGUDID - DEVICE: Welldoc (B553202301OTC0)

GUDID

Device Identifier (DI) Information

Brand Name: Welldoc
Version or Model: 3.X
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WELLDOC, INC.

Primary DI Number: B553202301OTC0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021217115 *Terms of Use

Device Description: The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCP) and their patients – aged 18 years and older – who have prediabetes, diabetes, heart failure, high blood pressure, liver disease, kidney disease, and/or sleep apnea. The Welldoc App also supports weight management and mental wellbeing. The patient 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 HCP. The software also generates electronic reports intended for a HCP. The web-based HCP software allows HCPs to view patient health data and communicate directly with their patients. 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. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their HCP when determining therapeutic strategies. The software provides educational content to encourage behaviors which may help living well with cardiometabolic conditions 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58884	Self-care monitoring/reporting software	An application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PHV	Continuous Glucose Monitor Retrospective Data Analysis Software
NXQ	Reminder, Medication

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fe4de435-aafa-48ab-b821-961e072582e2
Public Version Date: July 29, 2025
Public Version Number: 1
DI Record Publish Date: July 21, 2025