HVAD Pump Implant Kit 1103

GUDID 00888707000062

Heartware Inc.

Artificial heart, temporary
Primary Device ID00888707000062
NIH Device Record Key0ea3eb97-0afb-4e0b-953a-e853ec38736c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHVAD Pump Implant Kit
Version Model Number1103
Catalog Number1103
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
GS100888707000062 [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 Date2014-10-01

On-Brand Devices [HVAD Pump Implant Kit]

00888707003261A00118US
008887070000621103

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