Catalog Number

-

Brand Name

The Venous Assist System(DVT-2600)

Version/Model Number

DS214

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

K112677,K112677,K112677,K112677,K112677

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

4e972f03-5149-45da-9475-29921c2fd8d0

Public Version Date

June 24, 2021

Public Version Number

4

DI Record Publish Date

October 18, 2016

Package DI Number

38809315678637

Quantity per Package

4

Contains DI Package

18809315678633

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX