Breg

FDA UDI

Class I (US FDA UDI)

by Breg, Inc.

Identity

Trade Name: BREG FDA UDI
Generic Name: Circulating-fluid localized thermal therapy system pack, single-use FDA UDI
Model / Reference: TOPSHELF WRAP BACK L FDA UDI

Identifiers

Catalog Number: 20.02704 FDA UDI
Primary DI / UDI-DI: 00672736022191 FDA UDI
FDA Product Code: IME FDA UDI
GMDN Term: Circulating-fluid localized thermal therapy system pack, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.5700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Circulating-fluid localized thermal therapy system pack, single-use Inflatable hot/cold therapy pack/electric pump

Breg by Breg, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Breg, Inc.

Sources (1)

FDA UDI 1c0534a1-db57-473a-92d8-ff81bbaf04d3 34 fields · synced Jun 8, 2026