Serial Data Output

GUDID 04033817900863

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 ID	04033817900863
NIH Device Record Key	ccf80be0-9d66-4dc0-9dc7-97e3b1b07921
Commercial Distribution Status	In Commercial Distribution
Brand Name	Serial Data Output
Version Model Number	Module
Company DUNS	343225272
Company Name	LivaNova Deutschland GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04033817900863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K071318

FDA Product Code

DTQ	CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2024-05-07
Device Publish Date	2015-10-13

Devices Manufactured by LivaNova Deutschland GmbH

04033817753070 - XVAC	2024-05-07
04033817900023 - Venous Line Clamp	2024-05-07
04033817900030 - Venous Line Clamp	2024-05-07
04033817900047 - Venous Line Clamp	2024-05-07
04033817900054 - Venous Line Clamp	2024-05-07
04033817900061 - Venous Line Clamp	2024-05-07
04033817900078 - Venous Line Clamp	2024-05-07
04033817900085 - Venous Line Clamp	2024-05-07