Assy, Venous Drainage, Cannula Conversion, 1/2

GUDID 10803622128391

LIVANOVA USA, INC.

Arteriovenous/external shunt connector Arteriovenous/external shunt connector
Primary Device ID10803622128391
NIH Device Record Key858eb1ec-5b62-4875-9db4-b265a2292965
Commercial Distribution StatusIn Commercial Distribution
Brand NameAssy, Venous Drainage, Cannula Conversion, 1/2
Version Model NumberAX-xxxxx
Company DUNS080914995
Company NameLIVANOVA USA, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100803622128394 [Primary]
GS110803622128391 [Package]
Contains: 00803622128394
Package: CASE [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-15
Device Publish Date2015-09-22

Devices Manufactured by LIVANOVA USA, INC.

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00803622156533 - Perfusion Pack2024-04-23
00803622156540 - Perfusion Pack2024-04-23
10803622156554 - Perfusion Pack2024-04-23
10803622156561 - Perfusion Pack2024-04-23
10803622156592 - Cardioplegia Pack2024-04-23

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