Identity
- Trade Name
- FreeStyle Libre FDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
- Device Name
- FreeStyle Libre Sensor Kit FDA UDI
- Model / Reference
- 71536 FDA UDI
- Description
- FreeStyle Libre Sensor Kit FDA UDI
Identifiers
- Catalog Number
- 71536 FDA UDI
- Primary DI / UDI-DI
- 00357599000196 FDA UDI
- PMA Number
- P160030 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 by Abbott Diabetes Care Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P160030 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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Diabetes Care Inc
Sources (1)
- FDA UDI 93f04e28-de0d-4be6-b190-cb59f9b53d0b 38 fields · synced May 30, 2026