Catalog Number

-

Brand Name

NA

Version/Model Number

10G88R

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

K800178

Product Code

DWE

Product Code Name

TUBING, PUMP, CARDIOPULMONARY BYPASS

Public Device Record Key

5e8aaaf1-7ae0-4817-a950-ba8c9b5694be

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-