Catalog Number

HMT1100-R

Brand Name

HeartMate Touch™

Version/Model Number

HMT1100-R

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

-

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

Product Code

DSQ

Product Code Name

Ventricular (assist) bypass

Public Device Record Key

f09d9bd2-6f7b-4dc4-aa1f-862adcd9de8a

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

June 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-