Data Cable 1575

GUDID 00888707000208

Heartware Inc.

Artificial heart, temporary
Primary Device ID00888707000208
NIH Device Record Keyff7adc2f-f762-48f6-be6c-21e36a7c8e39
Commercial Distribution StatusIn Commercial Distribution
Brand NameData Cable
Version Model Number1575
Catalog Number1575
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
GS100888707000208 [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 [Data Cable]

008887070002081575
008887070101771575
008887070080511575

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