Identity
- Trade Name
- OKRA Pro Glucose meter FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Model / Reference
- IGM-1003F FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809115905376 FDA UDI
- 510(k) Number
- K182286 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose monitoring system IVD, home-use
OKRA Pro Glucose meter by OSANG HEALTHCARE Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glucose monitoring system IVD, home-use.
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- 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
Cleared under the same submission
K182286 also covers:
- OKRA Pro Glucose monitoring system starter kit — OSANG HEALTHCARE Co., Ltd.
- Oh'Care Lite Smart Glucose Test Strip — OSANG HEALTHCARE Co., Ltd.
- Oh'Care Lite Smart Glucose control solution-Level 1 — OSANG HEALTHCARE Co., Ltd.
- Oh'Care Lite Smart Glucose control solution-Level 3 — OSANG HEALTHCARE Co., Ltd.
- Oh'Care Lite Smart Glucose monitoring system — OSANG HEALTHCARE Co., Ltd.
- Oh'care Lite Smart Glucose Meter — OSANG HEALTHCARE Co., Ltd.
- Oh'care Lite Smart Glucose Test Strip — OSANG HEALTHCARE Co., Ltd.
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
- OSANG HEALTHCARE Co., Ltd.
Sources (1)
- FDA UDI 6f96f050-15e6-4864-846d-705eb394a0f0 34 fields · synced May 31, 2026