UpDoc

Basic Information

• Brand Name: UpDoc
• Primary DI: 00860015223906
• Version / Model: V1.0
• Company Name: UpDoc Inc.
• Labeler DUNS: 119383564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-13
• Public Version: 1
• Public Version Date: 2026-01-21
• Public Version Status: New
• Public Device Record Key: 6df0b787-eb63-4f24-b2fb-a63e1bb287f9

Device Description

Software as a medical device for insulin management in adults with type 2 diabetes.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDC	Calculator, Drug Dose	Anesthesiology	868.1890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65461	Insulin-injection patient guidance software	A software program intended to provide a diabetic patient on insulin injection therapy with a personalized and guided program, which may be prescribed by a clinician, on proper insulin injection technique (e.g., training on correct injection routines, site rotation, and injection-related behaviours) to help improve diabetes self-management. It is typically used by the patient in the home or similar environment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860015223906	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K253281	000