Catalog Number

-

Brand Name

Heart-Chill Cardiac & Phrenic Insulator

Version/Model Number

CPI-S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K874927,K874927

Product Code

DWC

Product Code Name

Controller, Temperature, Cardiopulmonary Bypass

Public Device Record Key

f7189504-056f-4630-9c85-43b5cf01b255

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 01, 2017

Package DI Number

B040CPIS2

Quantity per Package

1

Contains DI Package

B040CPIS1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-