Catalog Number

102515-SING

Brand Name

HeartMate, 14v Li-Ion Battery (SING)

Version/Model Number

102515-SING

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

8ae4440b-e1be-47cf-9450-0aeecb247ff3

Public Version Date

March 21, 2019

Public Version Number

5

DI Record Publish Date

August 06, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-