Catalog Number

-

Brand Name

Cardioplegia Plus

Version/Model Number

CPS02

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"

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

K875095,K875095

Product Code

JOD

Product Code Name

FILTER, BLOOD, CARDIOTOMY SUCTION LINE, CARDIOPULMONARY BYPASS

Public Device Record Key

5fcd5b7e-6fff-47d9-a7cf-c9b0c67f74ba

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 19, 2017

Package DI Number

30887691000301

Quantity per Package

40

Contains DI Package

10887691000307

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-