Identity
- Trade Name
- ONE-CARE FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- ONE-CARE 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 system can be used at home (over the counter OTC) by persons with diabetes. ONE-CARE glucose meter feature strip ejector for safe removal of used strip, large and user-friendly display, as well as 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. ONE-CARE glucose monitor automatically powers on and shuts down when the strip is inserted/ejected. FDA UDI
- Model / Reference
- AC500 FDA UDI
- Description
- ONE-CARE 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 system can be used at home (over the counter OTC) by persons with diabetes. ONE-CARE glucose meter feature strip ejector for safe removal of used strip, large and user-friendly display, as well as 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. ONE-CARE glucose monitor automatically powers on and shuts down when the strip is inserted/ejected. FDA UDI
Identifiers
- Catalog Number
- 4006 FDA UDI
- Primary DI / UDI-DI
- 00810008210161 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
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
Yes
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 cb44b534-e745-4929-a513-90efc0f1752f 36 fields · synced Jun 7, 2026