Catalog Number

701064327R01

Brand Name

OR Pack

Version/Model Number

BO-TOP 48400

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 21, 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

8d8a7b5b-857a-4a3e-a7dc-2a0890c7f538

Public Version Date

January 28, 2019

Public Version Number

5

DI Record Publish Date

March 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-