Identity
- Trade Name
- GLUCOFACTS® DELUXE FDA UDI
- Generic Name
- Self-care monitoring/reporting software FDA UDI
- Device Name
- Diabetes Management Software FDA UDI
- Model / Reference
- 3515 FDA UDI
- Description
- Diabetes Management Software FDA UDI
Identifiers
- Catalog Number
- 84450392 FDA UDI
- Primary DI / UDI-DI
- 00301933515013 FDA UDI
- FDA Product Code
- JQP FDA UDI
- GMDN Term
- Self-care monitoring/reporting software FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Self-care monitoring/reporting software
Glucofacts® Deluxe by Ascensia Diabetes Care Us Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K111268 also covers:
K121190 also covers:
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ascensia Diabetes Care Us Inc.
Sources (1)
- FDA UDI bdd4e750-bd12-475b-b7ab-22b755ce086e 36 fields · synced Jun 8, 2026