Catalog Number

FD-1001

Brand Name

Cardiac Insulation Pad Adult Sterile

Version/Model Number

Adult - Sterile

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K992932,K992932,K992932

Product Code

DWF

Product Code Name

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Public Device Record Key

a66474fd-fe23-4b3f-ae49-1d2e119f0c03

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 11, 2016

Package DI Number

05391530750141

Quantity per Package

8

Contains DI Package

05391530750134

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-