Identity
- Trade Name
- FreeStyle Libre 3 FDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
- Device Name
- FreeStyle Libre 3 Continuous Glucose Monitoring System Reader FDA UDI
- Model / Reference
- 72079 FDA UDI
- Description
- FreeStyle Libre 3 Continuous Glucose Monitoring System Reader FDA UDI
Identifiers
- Catalog Number
- 72079 FDA UDI
- Primary DI / UDI-DI
- 00357599820008 FDA UDI
- FDA Product Code
- QBJ FDA UDINBW FDA UDI
- GMDN Term
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1355 FDA UDI862.1345 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
Yes
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 3 by Abbott Diabetes Care Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Abbott Diabetes Care Inc
Sources (1)
- FDA UDI f96cee88-211a-4505-a802-45643899b8f7 36 fields · synced May 30, 2026