Air Purge Control (APC)

GUDID 04033817902638

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type
Primary Device ID04033817902638
NIH Device Record Key8e6223a6-7031-49c9-9d12-cb6fb7341075
Commercial Distribution StatusIn Commercial Distribution
Brand NameAir Purge Control (APC)
Version Model NumberSensor Module
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
GS104033817902638 [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 Date2021-05-24
Device Publish Date2021-05-14

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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