Catalog Number

1555US

Brand Name

HeartWare® Monitor AC Adapter

Version/Model Number

1555US

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

Yes

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

P100047

Product Code

DSQ

Product Code Name

Ventricular (Assisst) Bypass

Public Device Record Key

fe37cdda-5392-4f13-8482-f77b2ede2637

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-