Identity
- Trade Name
- GLUCOCARD® Shine Blood Glucose Monitoring System FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU FDA UDI
- Model / Reference
- 541199 FDA UDI
- Description
- Startup Portable Blood Glucose Meter System. Includes: meter, test strips, IFU FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30015482541997 FDA UDI
- 510(k) Number
- K120351 FDA UDI
- FDA Product Code
- CGA FDA UDINBW 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
- Not 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
No
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
GLUCOCARD® Shine Blood Glucose Monitoring System by Arkray Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K120351 also covers:
- ASSURE® Prism Blood Glucose Test Strips — ARKRAY USA, INC.
- GLUCOCARD® Shine BLOOD GLUCOSE TEST STRIPS — ARKRAY USA, INC.
- GLUCOCARD® Shine BLOOD GLUCOSE TEST STRIPS — ARKRAY USA, INC.
- GLUCOCARD® Shine Blood Glucose Monitoring System — ARKRAY USA, INC.
- GLUCOCARD® Shine Blood Glucose Monitoring System — ARKRAY USA, INC.
- Greater Goods — Greater Goods, LLC
- CareSens N POP — i-SENS, Inc.
- Fifty50 Sport — i-SENS, Inc.
- Greater Goods Essential — i-SENS, Inc.
- Greater Goods Essential — i-SENS, Inc.
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
- Arkray Usa, Inc.
Sources (1)
- FDA UDI d962d088-365e-44f9-85bf-448394a5b536 37 fields · synced May 30, 2026