Catalog Number

1225

Brand Name

THORATEC® HEARTMATE® XVE AND HEARTMATE II®, HEARTMATE TO POWER BASE UNIT CABLE

Version/Model Number

1225

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

-

Product Code

DSQ

Product Code Name

Ventricular (Assisst) Bypass

Public Device Record Key

6512d6d0-eae7-419c-a67c-f6a5990bf7db

Public Version Date

February 18, 2019

Public Version Number

5

DI Record Publish Date

September 20, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-