← Back to catalogue

Libre App

FDA UDI

Class II (US FDA UDI)

by Abbott Diabetes Care Inc

Identity

Trade Name
Libre App FDA UDI
Generic Name
Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
Device Name
Libre Android App US FDA UDI
Model / Reference
78745-01 FDA UDI
Description
Libre Android App US FDA UDI

Identifiers

Catalog Number
78745-01 FDA UDI
Primary DI / UDI-DI
00357599840006 FDA UDI
510(k) Number
K233537 FDA UDI
FDA Product Code
QBJ FDA UDI
QLG 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical

Libre App 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.

Cleared under the same submission

K233537 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Abbott Diabetes Care Inc

Sources (1)

  • FDA UDI 5e485d6b-99bb-4dbc-92a7-0d2236c36d7d 36 fields · synced Jun 8, 2026