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FreeStyle Libre 2

FDA UDI

Class II (US FDA UDI)

by Abbott Diabetes Care Inc

Identity

Trade Name
FreeStyle Libre 2 FDA UDI
Generic Name
Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
Device Name
FreeStyle Libre 2 Flash Glucose Monitoring System Reader FDA UDI
Model / Reference
71953 FDA UDI
Description
FreeStyle Libre 2 Flash Glucose Monitoring System Reader FDA UDI

Identifiers

Catalog Number
71953 FDA UDI
Primary DI / UDI-DI
00357599803018 FDA UDI
510(k) Number
K193371 FDA UDI
FDA Product Code
NBW 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
862.1345 FDA UDI
862.1355 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical

FreeStyle Libre 2 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

K193371 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Diabetes Care Inc

Sources (1)

  • FDA UDI 7e3d5bab-c5bf-4782-8074-ed1eba5c64e6 37 fields · synced May 30, 2026