HeartWare® Battery A00158

GUDID 00888707006897

Heartware Inc.

Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system
Primary Device ID00888707006897
NIH Device Record Key620ce637-e848-4cf8-b457-32256cacbc68
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeartWare® Battery
Version Model Number1650DE
Catalog NumberA00158
Company DUNS146054536
Company NameHeartware Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100888707006897 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSQVentricular (Assist) Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-07
Device Publish Date2020-06-29

On-Brand Devices [HeartWare® Battery]

008887070068731650DE
008887070057081650DE
008887070056921650DE
008887070026461650DE
008887070003761650
008887070003691650DE
008887070000791650
008887070068971650DE
008887070099421650DE
008887070087781650DE
007630006297171650DE

Trademark Results [HeartWare]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEARTWARE
HEARTWARE
90276962 not registered Live/Pending
Corgibytes, LLC
2020-10-25
HEARTWARE
HEARTWARE
90276943 not registered Live/Pending
Corgibytes, LLC
2020-10-25
HEARTWARE
HEARTWARE
85099764 3940614 Live/Registered
Heartware, Inc.
2010-08-04
HEARTWARE
HEARTWARE
78106198 2872528 Dead/Cancelled
HBI BRANDED APPAREL LIMITED, INC.
2002-02-01
HEARTWARE
HEARTWARE
77618461 3833371 Live/Registered
HeartWare Inc.
2008-11-20
HEARTWARE
HEARTWARE
77567404 3729557 Live/Registered
HeartWare, Inc.
2008-09-11
HEARTWARE
HEARTWARE
76550867 3151263 Live/Registered
HeartWare, Inc.
2003-10-14
HEARTWARE
HEARTWARE
76415781 not registered Dead/Abandoned
WALTERS, JACQUELYN LEIGH
2002-06-04
HEARTWARE
HEARTWARE
76037490 2541580 Live/Registered
Diehl, Berlinda E.
2000-05-01
HEARTWARE
HEARTWARE
75524102 2295587 Live/Registered
Prova Research Inc.
1998-07-23
HEARTWARE
HEARTWARE
74488180 not registered Dead/Abandoned
HEARTWARE, INC.
1994-02-08
HEARTWARE
HEARTWARE
74356218 1931905 Dead/Cancelled
Annika Systems Inc.
1993-02-05

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