Identity
- Trade Name
- Fifty50 Sport FDA UDI
- Generic Name
- Home-use/point-of-care blood glucose monitoring system IVD FDA UDI
- Device Name
- Fifty50 Sport Blood Glucose Monitoring System 2.0 FDA UDI
- Model / Reference
- 163424-201 FDA UDI
- Description
- Fifty50 Sport Blood Glucose Monitoring System 2.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00892896000260 FDA UDI
- 510(k) Number
- K120351 FDA UDI
- FDA Product Code
- CGA FDA UDINBW FDA UDI
- GMDN Term
- Home-use/point-of-care blood glucose monitoring system IVD 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Home-use/point-of-care blood glucose monitoring system IVD
Fifty50 Sport 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
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.
- 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
- i-SENS, Inc.
Sources (1)
- FDA UDI 391ad575-9ba6-4002-a321-853a46a686d8 36 fields · synced Jun 8, 2026