Identity
- Trade Name
- Fifty50 FDA UDI
- Generic Name
- Home-use/point-of-care blood glucose monitoring system IVD FDA UDI
- Device Name
- Fifty50 Blood Glucose Monitoring System 2.0 FDA UDI
- Model / Reference
- 163308-302 FDA UDI
- Description
- Fifty50 Blood Glucose Monitoring System 2.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00892896000086 FDA UDI
- 510(k) Number
- K083468 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 by i-SENS, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Home-use/point-of-care blood glucose monitoring system IVD.
- Embrace Gestational Diabetes Package - LARGE (9 vials) — OMNIS HEALTH, LLC · Class II
- Rightest — Bionime Corporation · Class II
- Embrace EVO Control Solution, L2 (Medium) — OMNIS HEALTH, LLC · Class I
- Embrace Strips, 50ct Vial - Mail Order (Yellow Band) — OMNIS HEALTH, LLC · Class II
- Smartest PersonaII — BIOTEST MEDICAL CORPORATION · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- Embrace Control Solution, L1 (Low) — OMNIS HEALTH, LLC · Class I
- GE — Bionime Corporation · Class II
Cleared under the same submission
K083468 also covers:
- GLUCOCARD® Shine XL Blood Glucose Monitoring System — ARKRAY USA, INC.
- GLUCOCARD® Shine XL Blood Glucose Monitoring System — ARKRAY USA, INC.
- CareSens N — i-SENS, Inc.
- CareSens N — i-SENS, Inc.
- CareSens N — i-SENS, Inc.
- CareSens N — i-SENS, Inc.
- CareSens N — i-SENS, Inc.
- CareSens N — i-SENS, Inc.
- CareSens N — i-SENS, Inc.
- CareSens N — i-SENS, Inc.
- CareSens N — i-SENS, Inc.
- CareSens N (MedPoint Diagnostics) — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- i-SENS, Inc.
Sources (1)
- FDA UDI 839a7f59-b4c1-432d-abf3-4aea8d6a1ab5 36 fields · synced Jun 1, 2026