Catalog Number

-

Brand Name

TandemHeart

Version/Model Number

5150-0004

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

-

Product Code

KRI

Product Code Name

Accessory Equipment, Cardiopulmonary Bypass

Public Device Record Key

1c339ef9-8c74-40fc-8402-c79875a06e88

Public Version Date

October 03, 2018

Public Version Number

3

DI Record Publish Date

October 10, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-