Identity
- Trade Name
- CONTOUR® NEXT ONE FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- Kit contains: CONTOUR® NEXT ONE Blood Glucose Monitoring System kit; MICROLET® NEXT Lancing Device; 4 bags of MICROLET® lancets (25 per bag; provided sterile) FDA UDI
- Model / Reference
- 9766 FDA UDI
- Description
- Kit contains: CONTOUR® NEXT ONE Blood Glucose Monitoring System kit; MICROLET® NEXT Lancing Device; 4 bags of MICROLET® lancets (25 per bag; provided sterile) FDA UDI
Identifiers
- Catalog Number
- 85677357 FDA UDI
- Primary DI / UDI-DI
- 40301939766011 FDA UDI
- 510(k) Number
- K160682 FDA UDI
- FDA Product Code
- LFR FDA UDINBW FDA UDI
- GMDN Term
- Glucose monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Contour® Next One by Ascensia Diabetes Care Us Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 II | Pending data |
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Manufacturer
- Manufacturer
- Ascensia Diabetes Care Us Inc.
Sources (1)
- FDA UDI e62e4b23-3f3d-4efa-9208-468525358a65 38 fields · synced Jun 8, 2026