Catalog Number

-

Brand Name

Reprocessed Venaflow Calf Cuff, Large, 1 Pair

Version/Model Number

3012

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 30, 2017

Issuing Agency

In HIBCC

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

K052691

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

e5935cb1-9f1b-48ea-adf0-e0942784a71a

Public Version Date

November 09, 2018

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-