Identity
- Trade Name
- COOL FDA UDI
- Generic Name
- Glucose IVD, reagent FDA UDI
- Device Name
- COOL Blood Glucose Test Strip FDA UDI
- Model / Reference
- 520050 FDA UDI
- Description
- COOL Blood Glucose Test Strip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885325000764 FDA UDI
- 510(k) Number
- K103396 FDA UDI
- FDA Product Code
- CGA FDA UDI
- GMDN Term
- Glucose IVD, reagent 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 IVD, reagent
Cool by i-SENS, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K103396 also covers:
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
- i-SENS, Inc.
Sources (1)
- FDA UDI 1e5f0452-7bff-4871-a285-fd9bef9ce762 36 fields · synced May 31, 2026