Catalog Number

-

Brand Name

Venous Femoral Cannula

Version/Model Number

V172-22

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

K001509,K001509

Product Code

DWF

Product Code Name

CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Public Device Record Key

78572a50-3487-4486-bfa7-b452fa37b8ed

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 21, 2016

Package DI Number

38033178003989

Quantity per Package

3

Contains DI Package

08033178003988

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX