S5 Console

GUDID 04033817903123

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type
Primary Device ID04033817903123
NIH Device Record Key0d66ca5c-eae0-4b0d-a3f5-f88930c29c29
Commercial Distribution StatusIn Commercial Distribution
Brand NameS5 Console
Version Model NumberCP5 Console
Company DUNS343225272
Company NameLivaNova Deutschland GmbH
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 Usefalse
Lot Batchfalse
Serial Numbertrue
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
GS104033817903123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTQCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-03
Device Publish Date2021-08-26

On-Brand Devices [S5 Console]

04033817902751S5 Min.I.
040338179026835-position
040338179026764-position
040338179026693-position
04033817903123CP5 Console
040338179009005-position
040338179008944-position
040338179008873-position
04033817900535Ice Container

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