Catalog Number

709000093

Brand Name

Adult ECC Pack

Version/Model Number

BO TOP 28903

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)

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

b590f1e0-1ff8-4124-8de7-b2564d7dcf58

Public Version Date

July 20, 2018

Public Version Number

3

DI Record Publish Date

February 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-