Catalog Number

-

Brand Name

The Venous Assist System

Version/Model Number

DVT-2600

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K112677

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

3f84747a-ffeb-46c5-b48d-12d6a907a6e9

Public Version Date

June 24, 2021

Public Version Number

4

DI Record Publish Date

October 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-