Identity
- Trade Name
- FreeStyle Libre 14 day FDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
- Device Name
- FreeStyle Libre 14 day Sensor Kit NFRS FDA UDI
- Model / Reference
- 71939 FDA UDI
- Description
- FreeStyle Libre 14 day Sensor Kit NFRS FDA UDI
Identifiers
- Catalog Number
- 71939 FDA UDI
- Primary DI / UDI-DI
- 00357599001025 FDA UDI
- FDA Product Code
- PZE FDA UDI
- GMDN Term
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
FreeStyle Libre 14 day by Abbott Diabetes Care Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 III | Pending data |
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Manufacturer
- Manufacturer
- Abbott Diabetes Care Inc
Sources (1)
- FDA UDI 534a7f7b-8484-4426-9844-f58d619bab95 37 fields · synced Jun 6, 2026