Patient Pack 1475

GUDID 00888707000178

Heartware Inc.

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Primary Device ID00888707000178
NIH Device Record Key5873dbe9-f8ca-4fa4-ae07-69f40ac0a452
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatient Pack
Version Model Number1475
Catalog Number1475
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100888707000178 [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 [Patient Pack]

008887070001781475
008887070080371475

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