Catalog Number

C00034

Brand Name

BREG

Version/Model Number

VPULSE THERM PAD ANKL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K122640

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

90f3c38f-f0b0-4a16-9dbb-99cb83736e00

Public Version Date

December 21, 2018

Public Version Number

4

DI Record Publish Date

August 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-