← Back to catalogue
Oh’Care Lite Blood Glucose Monitoring System for Self-Testing
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Oh’Care Lite Blood Glucose Monitoring System for Self-Testing FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- Blood Glucose Monitoring System for Self-Testing FDA UDI
- Model / Reference
- IGM-1003A FDA UDI
- Description
- Blood Glucose Monitoring System for Self-Testing FDA UDI
Identifiers
- Catalog Number
- INFM003L FDA UDI
- Primary DI / UDI-DI
- 00793150629770 FDA UDI
- FDA Product Code
- NBW FDA UDILFR 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 0.5 Microliter FDA UDI
Category: Glucose monitoring system IVD, home-use
Oh’Care Lite Blood Glucose Monitoring System for Self-Testing by OSANG HEALTHCARE Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
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
- OSANG HEALTHCARE Co., Ltd.
Sources (1)
- FDA UDI 1d2dafd6-c082-44eb-bec6-976c146a5c25 35 fields · synced May 30, 2026