T1D1

Basic Information

• Brand Name: T1D1
• Primary DI: 07649994217037
• Version / Model: RX.X.X
• Company Name: Comerge AG
• Labeler DUNS: 484668533
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-28
• Public Version: 1
• Public Version Date: 2025-09-05
• Public Version Status: New
• Public Device Record Key: 95c8428b-ff0a-4f4f-8bfd-dde2dca0d30f

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
66082	Diabetes patient management software	A software program with a patient user interface intended to be used on a non-medical computerized device to calculate therapeutic insulin doses, based on both blood glucose data and patient lifestyle/diet data, for the management of diabetes. Designed to be used exclusively by the patient, it has no clinician facing application, although outputs can be used within the broader context of clinical guidance. It is not considered an in vitro diagnostic (IVD) software application and is not intended for diabetes screening or diagnosis. 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	07649994217037	GS1

Premarket Submissions

Submission Number	Supplement Number
K252104	000