Catalog Number

107754OUS

Brand Name

HEARTMATE MOBILE POWER UNIT, CA

Version/Model Number

107754OUS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 11, 2018

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

-

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

DSQ

Product Code Name

Ventricular (Assisst) Bypass

Public Device Record Key

ef3c6c0d-beff-47b5-a1a7-1ee9f5a4e880

Public Version Date

July 22, 2021

Public Version Number

7

DI Record Publish Date

January 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-