HVAD® Pump Outflow Graft 1125

GUDID 00888707007641

Heartware Inc.

Implantable ventricular circulatory assist system
Primary Device ID00888707007641
NIH Device Record Keye4eae4d9-e573-4d99-ad90-92abd0fd5438
Commercial Distribution StatusIn Commercial Distribution
Brand NameHVAD® Pump Outflow Graft
Version Model Number1125
Catalog Number1125
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100888707007641 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-04-20
Device Publish Date2020-11-10

On-Brand Devices [HVAD® Pump Outflow Graft]

008887070002221125
00888707007634MCS1725OG
008887070076411125

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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