Alarm Adapter 1450

GUDID 00888707010160

Heartware Inc.

Implantable ventricular circulatory assist system
Primary Device ID00888707010160
NIH Device Record Key8ee4e789-96c4-48de-ad01-a9cbe4cbb8c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlarm Adapter
Version Model Number1450
Catalog Number1450
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
GS100888707010160 [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 [Alarm Adapter ]

008887070001611450
008887070101601450
008887070080201450

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