S5 Power Supply

GUDID 04033817901082

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type
Primary Device ID04033817901082
NIH Device Record Key78f55cdc-d06e-4847-b363-c612b31b1c4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameS5 Power Supply
Version Model NumberModule
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 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
GS104033817901082 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-05-07
Device Publish Date2015-10-20

Devices Manufactured by LivaNova Deutschland GmbH

04033817901693 - Virtual Kit Number2024-07-31
04033817753070 - XVAC2024-05-07
04033817900023 - Venous Line Clamp2024-05-07
04033817900030 - Venous Line Clamp2024-05-07
04033817900047 - Venous Line Clamp2024-05-07
04033817900054 - Venous Line Clamp2024-05-07
04033817900061 - Venous Line Clamp2024-05-07
04033817900078 - Venous Line Clamp2024-05-07

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