Identity
- Trade Name
- CONTOUR® FDA UDI
- Generic Name
- Glucose IVD, control FDA UDI
- Device Name
- Control Solution - Normal, 1 x 2.5 mL FDA UDI
- Model / Reference
- 7109B FDA UDI
- Description
- Control Solution - Normal, 1 x 2.5 mL FDA UDI
Identifiers
- Catalog Number
- 6707431 FDA UDI
- Primary DI / UDI-DI
- 10301937109017 FDA UDI
- FDA Product Code
- NBW FDA UDIJJX FDA UDI
- GMDN Term
- Glucose IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI862.1660 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Contour® by Ascensia Diabetes Care Us Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K062058 also covers:
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 4d135aa0-eb49-4352-91ae-8c063b5901b2 38 fields · synced Jun 8, 2026