HVAD® Pump Implant Accessories MCS1753AK

GUDID 00888707005371

Heartware Inc.

Implantable ventricular circulatory assist system
Primary Device ID00888707005371
NIH Device Record Key446603e6-e641-473e-8b82-b08e277e028c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHVAD® Pump Implant Accessories
Version Model NumberMCS1753AK
Catalog NumberMCS1753AK
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 Batchtrue
Serial Numberfalse
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
GS100888707005371 [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 Date2020-12-22
Device Publish Date2020-12-14

On-Brand Devices [HVAD® Pump Implant Accessories]

008887070001471153
00888707005371MCS1753AK

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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