Identity
- Trade Name
- ONE-CARE FDA UDI
- Generic Name
- Glucose IVD, control FDA UDI
- Device Name
- ONE-CARE Control Solution (Level 1 – Low and Level 3 - High) contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the ONE-CARE test strip bottle label. FDA UDI
- Model / Reference
- AC500 FDA UDI
- Description
- ONE-CARE Control Solution (Level 1 – Low and Level 3 - High) contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the ONE-CARE test strip bottle label. FDA UDI
Identifiers
- Catalog Number
- 4010 FDA UDI
- Primary DI / UDI-DI
- 00810008210987 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Glucose IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose IVD, control
One-Care by MediVena, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- MediVena, LLC
Sources (1)
- FDA UDI 01ed7702-63c7-424c-92a5-20e50151041a 36 fields · synced Jun 8, 2026