Data Cable 1575

GUDID 00888707010177

Heartware Inc.

Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system
Primary Device ID00888707010177
NIH Device Record Key8c4af23b-7246-4d2c-998d-8e97408005a4
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
GS100888707010177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSQVentricular (Assist) Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-23
Device Publish Date2022-08-15

On-Brand Devices [Data Cable ]

008887070002081575
008887070101771575
008887070080511575

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