Catalog Number

-

Brand Name

Venous cardiopulmonary bypass cannula

Version/Model Number

RD-xxxxx

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

32a31a13-7b9a-421b-90da-2f5e3ffdec4b

Public Version Date

August 05, 2022

Public Version Number

5

DI Record Publish Date

September 17, 2015

Package DI Number

10803622128223

Quantity per Package

1

Contains DI Package

00803622128226

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE