Explant Kit 1750

GUDID 00888707000215

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 ID00888707000215
NIH Device Record Key7c5941cc-bda2-495f-9a90-8d71dd824c31
Commercial Distribution StatusIn Commercial Distribution
Brand NameExplant Kit
Version Model Number1750
Catalog Number1750
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100888707000215 [Primary]

FDA Product Code

DSQVentricular (Assisst) Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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 [Explant Kit]

008887070002151750
008887070087851750

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