Catalog Number

-

Brand Name

CSC 14

Version/Model Number

CSC14 + PURGE LINE

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

K012898,K012898

Product Code

DTR

Product Code Name

HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Public Device Record Key

d8691b33-45cb-4ca5-80d9-d1c0e2ddc6b4

Public Version Date

December 11, 2019

Public Version Number

4

DI Record Publish Date

July 10, 2015

Package DI Number

38033178109063

Quantity per Package

20

Contains DI Package

08033178109062

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX