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Breg

FDA UDI

Class II (US FDA UDI)

by Breg, Inc.

Identity

Trade Name
BREG FDA UDI
Generic Name
Multi-chamber venous compression system garment, single-use FDA UDI
Model / Reference
VPULSE SEQ COMP PAD (2) FDA UDI

Identifiers

Catalog Number
C00006 FDA UDI
Primary DI / UDI-DI
00672736064986 FDA UDI
510(k) Number
K122640 FDA UDI
FDA Product Code
JOW FDA UDI
GMDN Term
Multi-chamber venous compression system garment, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5800 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multi-chamber venous compression system garment, single-useCirculating-fluid localized thermal/compression therapy system control unit

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

Similar devices

Also classified as Circulating-fluid localized thermal/compression therapy system control unit.

Cleared under the same submission

K122640 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Breg, Inc.

Sources (1)

  • FDA UDI 7e872d92-37ea-4f63-9f0e-ce651c1e0228 35 fields · synced May 30, 2026