Catalog Number

6067

Brand Name

A-V Impulse

Version/Model Number

6067

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JOW

Product Code Name

SLEEVE, LIMB, COMPRESSIBLE

Public Device Record Key

6d3570ac-8cb7-477e-b194-d61d2adcd122

Public Version Date

April 15, 2019

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20884521077277

Quantity per Package

4

Contains DI Package

10884521077270

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE