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FreeStyle Libre Pro

FDA UDI

Class I (US FDA UDI)

by Abbott Diabetes Care Inc

Identity

Trade Name
FreeStyle Libre Pro FDA UDI
Generic Name
Home healthcare information system application software FDA UDI
Device Name
FreeStyle Libre Pro Software FDA UDI
Model / Reference
75170 FDA UDI
Description
FreeStyle Libre Pro Software FDA UDI

Identifiers

Catalog Number
75170 FDA UDI
Primary DI / UDI-DI
00093815751700 FDA UDI
FDA Product Code
PHV FDA UDI
GMDN Term
Home healthcare information system application software FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2120 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Home healthcare information system application software

FreeStyle Libre Pro by Abbott Diabetes Care Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Home healthcare information system application software.

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 3f79de73-3fb9-415a-842c-5f4caf29c537 35 fields · synced May 30, 2026