Catalog Number

-

Brand Name

Aortic Arch Cannula

Version/Model Number

NA-xxxxx

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

K943934,K943934

Product Code

DWF

Product Code Name

CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Public Device Record Key

0a27e26d-fe8f-42b2-b34b-55056abe7b2b

Public Version Date

August 05, 2022

Public Version Number

5

DI Record Publish Date

July 23, 2015

Package DI Number

10803622124416

Quantity per Package

10

Contains DI Package

00803622124419

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE