Heater-Cooler

GUDID 04033817901549

LivaNova Deutschland GmbH

Cardiopulmonary bypass system heating/cooling unit
Primary Device ID04033817901549
NIH Device Record Keyfe13b34f-a9cb-4422-81d8-5e338ffecc6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeater-Cooler
Version Model NumberWater Tubing 25m
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
GS104033817901549 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWCController, temperature, cardiopulmonary bypass

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-23
Device Publish Date2015-10-20

Devices Manufactured by LivaNova Deutschland GmbH

04033817902423 - Accessories2023-03-29
04033817902430 - Accessories2023-03-29
04033817902447 - Accessories2023-03-29
04033817902454 - Accessories2023-03-29
04033817902461 - Accessories2023-03-29
04033817902478 - Accessories2023-03-29
04033817902485 - Accessories2023-03-29
04033817902492 - Accessories2023-03-29

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