Identity
- Trade Name
- ONE-CARE FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- ONE-CARE PRO glucose monitoring system is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). ONE-CARE PRO system can be used by healthcare professionals in multi-patient setting. ONE-CARE PRO glucose meter feature strip ejector for convenient removal of used strip, large and user-friendly display, as well as small blood samples size of 0.5ul to provide test results within 5 seconds. The system is based on auto-coding technology and no programming is needed when using new batch of test strips. ONE-CARE PRO glucose meter automatically powers on and shuts down when the strip is inserted/ejected. FDA UDI
- Model / Reference
- AC500 PRO FDA UDI
- Description
- ONE-CARE PRO glucose monitoring system is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). ONE-CARE PRO system can be used by healthcare professionals in multi-patient setting. ONE-CARE PRO glucose meter feature strip ejector for convenient removal of used strip, large and user-friendly display, as well as small blood samples size of 0.5ul to provide test results within 5 seconds. The system is based on auto-coding technology and no programming is needed when using new batch of test strips. ONE-CARE PRO glucose meter automatically powers on and shuts down when the strip is inserted/ejected. FDA UDI
Identifiers
- Catalog Number
- 4001 FDA UDI
- Primary DI / UDI-DI
- 00810008210031 FDA UDI
- FDA Product Code
- NBW 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
- 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
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: Glucose monitoring system IVD, home-useGlucose monitoring system IVD, point-of-care
One-Care by MediVena, LLC — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- MediVena, LLC
Sources (1)
- FDA UDI d16904bb-82c0-46c1-8fd3-1cdff5f189fb 36 fields · synced Jun 8, 2026