ESSENZ

GUDID 04033817903017

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	04033817903017
NIH Device Record Key	f8700242-a51c-44e8-b5d4-ad31b7840945
Commercial Distribution Status	In Commercial Distribution
Brand Name	ESSENZ
Version Model Number	ILBM Sensor 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	04033817903017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K232291

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	2
Public Version Date	2024-05-07
Device Publish Date	2024-02-22

On-Brand Devices [ESSENZ]

04033817903178	Perfusion System Monitor
04033817903161	Patient Monitor Software
04033817903321	Mains/Interface-Box
04033817903307	Level Module
04033817903291	Temperature Module
04033817903284	Pressure Module
04033817903277	Flow Module
04033817903260	Bubble Module
04033817903154	CPED
04033817903116	Arterial Clamp- AC arm long (620 mm)
04033817903109	Arterial Clamp - AC arm short (500mm)
04033817903093	Venous clamp
04033817903086	RP85
04033817903079	Control Unit
04033817903062	HLM
04033817903055	Power Pack
04033817903048	Cockpit
04033817903031	CPD
04033817903024	BCP
04033817902997	RP150
04033817903017	ILBM Sensor Module

Trademark Results [ESSENZ]

Mark Image Registration \| Serial	Company Trademark Application Date
ESSENZ 90227474 not registered Live/Pending	LivaNova USA, INC. 2020-09-30
ESSENZ 79310281 not registered Live/Pending	FULI SPÃLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA 2021-02-26
ESSENZ 78552214 not registered Dead/Abandoned	ESSENCE STUDIO CORP. 2005-01-22