Identity
- Trade Name
- FreeStyle Libre 2 Plus FDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
- Device Name
- FreeStyle Libre 2 Plus Sensor Not For Retail Sale FDA UDI
- Model / Reference
- 78749 FDA UDI
- Description
- FreeStyle Libre 2 Plus Sensor Not For Retail Sale FDA UDI
Identifiers
- Catalog Number
- 78749 FDA UDI
- Primary DI / UDI-DI
- 00357599836016 FDA UDI
- FDA Product Code
- QBJ 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 UDI
- Commercial Distribution
- 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 2 Plus by Abbott Diabetes Care Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Percutaneous interstitial fluid glucose monitoring system, electrochemical.
- Simplera Sync™ — MEDTRONIC MINIMED, INC. · Class III
- Dexcom G7 GSS (151) — Dexcom · Class II
- Simplera Sync™ — MEDTRONIC MINIMED, INC. · Class III
- Dexcom G7 AR Overlay 10-Pack — Dexcom · Class I
- Stelo Glucose Biosensor (1pk) — Dexcom · Class II
- Guardian™ Transmitter Kit — MEDTRONIC MINIMED, INC. · Class III
- MiniLink® — MEDTRONIC MINIMED, INC. · Class III
- Dexcom G7 GSS (155) — Dexcom · Class II
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
- Abbott Diabetes Care Inc
Sources (1)
- FDA UDI 36bdff4f-2967-4ab4-b83c-d5df6b03b67a 36 fields · synced May 30, 2026