FDA.reportPublic FDA data

T1D1

Primary DI
07649994217037
Brand
T1D1
Company
Comerge AG
Model
RX.X.X
Published
2025-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NDCCalculator, Drug Dose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDCCalculator, Drug DoseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252104000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252104000T1D1Comerge AG2025-08-20NDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07649994217037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07649994217037076499942170377649994217037

GMDN Terms#

Term, Definition table
TermDefinition
Diabetes patient management softwareA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
484668533
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07649994217013Neo ADVISER2.X.Y2025-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150002375MiniMed AppMEDTRONIC MINIMED, INC.NDC2026-05-25
00199150002382MiniMed AppMEDTRONIC MINIMED, INC.NDC2026-05-25
00860008440129iSage Rx Amalgam RX, Inc.NDC2026-04-22
B553202153OTC0Conifer Connect DiabetesWELLDOC, INC.NDC2026-03-30
00860015223906UpDocUpDoc Inc.NDC2026-01-13
B553202401OTC0Welldoc RxWELLDOC, INC.NDC2025-12-09
B553202402RX0Welldoc RxWELLDOC, INC.NDC2025-12-09
B553202403OTC0Welldoc RxWELLDOC, INC.NDC2025-12-09
B553202404RX0Welldoc RxWELLDOC, INC.NDC2025-12-09
B553202405RX0Welldoc RxWELLDOC, INC.NDC2025-12-09
00199150047000MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.NDC2025-11-08
00199150047024MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.NDC2025-11-08
00199150047048MiniMed 780G Insulin pumpMEDTRONIC MINIMED, INC.NDC2025-11-08
00199150047055MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.NDC2025-11-08
10385082000009Omnipod DASH PDMInsulet CorporationNDC2025-08-25
B553202251OTC0WelldocWELLDOC, INC.NDC2025-05-29
B553202252RX0WelldocWELLDOC, INC.NDC2025-05-29
B553202253OTC0WelldocWELLDOC, INC.NDC2025-05-29
B553202254RX0WelldocWELLDOC, INC.NDC2025-05-29
B553202256RX0WelldocWELLDOC, INC.NDC2025-05-29
00763000974589InPenMEDTRONIC MINIMED, INC.NDC2025-04-29
00763000974596InPenMEDTRONIC MINIMED, INC.NDC2025-04-29
B553202145RX0LivingConnected Diabetes RxWELLDOC, INC.NDC2025-04-11
00763000489953InPen Smart Insulin Delivery SystemMEDTRONIC MINIMED, INC.NDC2025-03-08
00763000489960InPen Smart Insulin Delivery SystemMEDTRONIC MINIMED, INC.NDC2025-03-08
00850005949558BioButton (Reprocessed)BIOINTELLISENSE, INC.NDC2025-02-19
00850005949565BioButton (Reprocessed, NF Version)BIOINTELLISENSE, INC.NDC2025-02-19
00860003340639EndoTool IV MONARCH MEDICAL TECHNOLOGIES LLCNDC2025-01-02
B553202141OTC0LivingConnected Diabetes RxWELLDOC, INC.NDC2024-12-04
B553202142RX0LivingConnected DiabetesWELLDOC, INC.NDC2024-12-04