HVAD® Pump Implant Kit MCS1705PU

GUDID 00888707009041

Heartware Inc.

Implantable ventricular circulatory assist system
Primary Device ID00888707009041
NIH Device Record Keyf65e5fa6-6350-46a5-abcc-7a2c3e2a9c21
Commercial Distribution StatusIn Commercial Distribution
Brand NameHVAD® Pump Implant Kit
Version Model NumberMCS1705PU
Catalog NumberMCS1705PU
Company DUNS146054536
Company NameHeartware Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
GS100888707009041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSQVentricular (Assist) Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-09
Device Publish Date2021-03-01

On-Brand Devices [HVAD® Pump Implant Kit]

008887070026391103
00888707005364MCS1705PU
00888707009041MCS1705PU

Trademark Results [HVAD]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HVAD
HVAD
85758552 not registered Dead/Abandoned
HeartWare Inc.
2012-10-19
HVAD
HVAD
78910214 3730135 Live/Registered
HeartWare, Inc.
2006-06-16

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