Catalog Number

10002151

Brand Name

HeartMate™

Version/Model Number

10002151

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

P060040,P160054,P060040,P160054,P060040,P160054

Product Code

DSQ

Product Code Name

Ventricular (assist) bypass

Public Device Record Key

2212ebcc-5e70-4383-bbfe-5f5856bdd5ea

Public Version Date

September 20, 2022

Public Version Number

1

DI Record Publish Date

September 12, 2022

Package DI Number

15415067038279

Quantity per Package

6

Contains DI Package

05415067038272

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-