S5 Shelf for Gas Blender

GUDID 04033817901358

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type
Primary Device ID04033817901358
NIH Device Record Keye2611334-20e6-4470-8dbe-a43f9da2153c
Commercial Distribution StatusIn Commercial Distribution
Brand NameS5 Shelf for Gas Blender
Version Model Number3 pos.
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
GS104033817901358 [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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.