Catalog Number

-

Brand Name

Cardiac Insulation Pad

Version/Model Number

CIPI

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

K781990,K781990

Product Code

DWF

Product Code Name

CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Public Device Record Key

9126b54c-bc62-46c2-ba0b-2689302dec2c

Public Version Date

August 15, 2018

Public Version Number

4

DI Record Publish Date

May 13, 2016

Package DI Number

10803622131896

Quantity per Package

10

Contains DI Package

00803622131899

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE