← Back to catalogue

FreeStyle LibreLink

FDA UDI

Class III (US FDA UDI)

by Abbott Diabetes Care Inc

Identity

Trade Name
FreeStyle LibreLink FDA UDI
Generic Name
Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
Device Name
FreeStyle LibreLink Android US FDA UDI
Model / Reference
71732-01 FDA UDI
Description
FreeStyle LibreLink Android US FDA UDI

Identifiers

Catalog Number
71732-01 FDA UDI
Primary DI / UDI-DI
00357599000042 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
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

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

Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical

FreeStyle LibreLink by Abbott Diabetes Care Inc — Class III — 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

P160030 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 5153c7c8-55ff-4b65-b754-dadd2b2a85df 36 fields · synced Jun 8, 2026