Interface

GUDID 04033817900856

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	04033817900856
NIH Device Record Key	afb1f54d-6b34-435c-b0a8-728340954dba
Commercial Distribution Status	In Commercial Distribution
Brand Name	Interface
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	04033817900856 [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	2015-10-20

On-Brand Devices [Interface]

04033817901150	Module DDD
04033817900856	Module

Trademark Results [Interface]

Mark Image Registration \| Serial	Company Trademark Application Date
INTERFACE 97494900 not registered Live/Pending	Stratia Inc. 2022-07-08
INTERFACE 97048941 not registered Live/Pending	WS Acquisition, LLC 2021-09-28
INTERFACE 90895390 not registered Live/Pending	RAMSEY BEN 2021-08-21
INTERFACE 90172211 not registered Live/Pending	The Interface Collective LLC 2020-09-10
INTERFACE 88373835 not registered Live/Pending	Interface, Inc. 2019-04-05
INTERFACE 88349165 not registered Live/Pending	Payjo, Inc. 2019-03-20
INTERFACE 88283629 not registered Live/Pending	INTERFACE FILMS LLC 2019-01-31
INTERFACE 87780538 not registered Live/Pending	Storace, Paul 2018-02-01
INTERFACE 87724845 5564251 Live/Registered	Interface, Inc. 2017-12-18
INTERFACE 87708355 5534018 Live/Registered	Interface, Inc. 2017-12-05
INTERFACE 87620636 5453163 Live/Registered	Dalton Maag Ltd 2017-09-25
INTERFACE 86307830 4918827 Live/Registered	Comfort Lab Inc. 2014-06-12