HVAD® Pump Surgical Tools 1317

GUDID 00888707000185

Heartware Inc.

Artificial heart, temporary Artificial heart, temporary Artificial heart, temporary Artificial heart, temporary Artificial heart, temporary Artificial heart, temporary Artificial heart, temporary Artificial heart, temporary Artificial heart, temporary Artificial heart, temporary Artificial heart, temporary Artificial heart, temporary Artificial heart, temporary Artificial heart, temporary Artificial heart, temporary Artificial heart, temporary Artificial heart, temporary Artificial heart, temporary Artificial heart, temporary
Primary Device ID00888707000185
NIH Device Record Key71c72993-fe0b-4a17-b83b-158b1b1ddbe4
Commercial Distribution StatusIn Commercial Distribution
Brand NameHVAD® Pump Surgical Tools
Version Model Number1317
Catalog Number1317
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
GS100888707000185 [Primary]

FDA Product Code

DSQVentricular (Assisst) Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2014-08-14

On-Brand Devices [HVAD® Pump Surgical Tools]

008887070001851317
008887070001541318
00888707005388MCS1718ST
008887070082041318

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.