Identity
- Trade Name
- ONE-CARE FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- ONE-CARE test strips are intended for use with ONE-CARE glucose meters for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). ONE-CARE system can be used at home (over the counter OTC) by persons with diabetes. Test strips require small blood samples size of 0.5ul to provide accurate and fast results within 5 seconds. The system is based on auto-coding technology and no programming is needed when using new batch of test strips. FDA UDI
- Model / Reference
- AC500 FDA UDI
- Description
- ONE-CARE test strips are intended for use with ONE-CARE glucose meters for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). ONE-CARE system can be used at home (over the counter OTC) by persons with diabetes. Test strips require small blood samples size of 0.5ul to provide accurate and fast results within 5 seconds. The system is based on auto-coding technology and no programming is needed when using new batch of test strips. FDA UDI
Identifiers
- Catalog Number
- 4007 FDA UDI
- Primary DI / UDI-DI
- 00810008210369 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose monitoring system IVD, home-use
One-Care by MediVena, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glucose monitoring system IVD, home-use.
- Gmate® Origin Blood Glucose Monitoring System — Philosys, Inc. · Class II
- One Drop — INFORMED DATA SYSTEMS INC. · Class II
- TRUE METRIX GO — TRIVIDIA HEALTH, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- ReliOn® Confirm/micro Blood Glucose Test Strips — Walmart Stores · Class II
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC. · Class II
- LEADER — Cardinal Health 110, Inc. · Class II
- CareSens N Voice Multi — i-SENS, Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MediVena, LLC
Sources (1)
- FDA UDI 7be6efee-a514-458f-8c34-7ba6ccfd754c 36 fields · synced May 30, 2026