Catalog Number

701067370

Brand Name

Open Heart Pack w/o Plegiox

Version/Model Number

BO-TOP 38803

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 12, 2017

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)

Yes

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

-

Product Code

DWF

Product Code Name

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Public Device Record Key

f2b89de4-d647-48f3-91e0-3383bac7e011

Public Version Date

January 28, 2019

Public Version Number

4

DI Record Publish Date

January 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-