Catalog Number

1520US

Brand Name

HeartWare® Monitor

Version/Model Number

1520US

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

84fbebe0-62ef-4b57-83a8-f46d57fa9f6c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 14, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-