Catalog Number

-

Brand Name

NA

Version/Model Number

CB11G64R

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K171979,K171979

Product Code

DWF

Product Code Name

Catheter, cannula and tubing, vascular, cardiopulmonary bypass

Public Device Record Key

2e648e11-d48f-4a0f-9261-4181ba46e968

Public Version Date

April 27, 2020

Public Version Number

1

DI Record Publish Date

April 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-