Catalog Number

-

Brand Name

NA

Version/Model Number

BB7L75R3

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

K171979,K171979

Product Code

DWF

Product Code Name

Catheter, cannula and tubing, vascular, cardiopulmonary bypass

Public Device Record Key

20f76a26-356e-4f6d-b568-c96e6e62b473

Public Version Date

January 22, 2021

Public Version Number

1

DI Record Publish Date

January 14, 2021

Package DI Number

20763000489445

Quantity per Package

10

Contains DI Package

00763000489434

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK