Catalog Number

709000004

Brand Name

Small Adult Cardiac Surgery Pack

Version/Model Number

BO-T 2303

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 20, 2018

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"

Yes

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

-

Product Code

DWF

Product Code Name

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Public Device Record Key

7b1a2956-a721-4c60-b06f-5a6652c1d039

Public Version Date

January 28, 2019

Public Version Number

5

DI Record Publish Date

May 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-