LifeSPARC

GUDID 00814112020654

Removable Batteries of LifeSPARC blood pump controller

CARDIACASSIST, INC.

Cardiopulmonary bypass system centrifugal pump drive unit
Primary Device ID00814112020654
NIH Device Record Keya673c032-e657-4bc5-8ef8-d6d5b09107f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameLifeSPARC
Version Model Number5900-0004
Company DUNS948683941
Company NameCARDIACASSIST, INC.
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18003737421
Emailtl.regulatory@livanova.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100814112020654 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWAControl, Pump Speed, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-26
Device Publish Date2019-12-18

On-Brand Devices [LifeSPARC]

00814112020807LifeSPARC Blood Pump Kit with 31 Fr ProtekDuo Veno-Venous Rapid Depolyment Cannula
00814112020791LifeSPARC Blood Pump Kit with 31 Fr ProtekDuo Veno-Venous Cannula
00814112020784LifeSPARC Blood Pump Kit with 29 Fr ProtekDuo Veno-Venous Cannula
00814112020746LifeSPARC Blood Pump Kit with 72cm Transseptal Cannula and 15Fr Arterial Cannula
00814112020739LifeSPARC Blood Pump Kit with 72cm Transseptal Cannula and 17Fr Arterial Cannula
00814112020722LifeSPARC Blood Pump Kit with 62cm Transseptal Cannula and 15Fr Arterial Cannula
00814112020715LifeSPARC Blood Pump Kit with 62cm Transseptal Cannula and 17Fr Arterial Cannula
00814112020654Removable Batteries of LifeSPARC blood pump controller
00814112020647Power cord for blood pump controller charging station
00814112020616LifeSPARC holster, blood pump securement accessory
00814112020593LifeSPARC blood pump kit with accessories
00814112020579Flow Sensor
00814112020562Blood pump controller, charging station, Power cord, flow sensor, removable batteries
00814112020814LifeSPARC Priming Tray Accessory Kit
00814112020609LifeSPARC Priming Tray Kit: LIfeSPARC Blood Pump with TandemLung Oxygenator
00814112020906IV Pole Clamp for blood pump controller
00814112020586Controller Battery

Trademark Results [LifeSPARC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LIFESPARC
LIFESPARC
88646699 not registered Live/Pending
LIVANOVA USA, INC.
2019-10-08
LIFESPARC
LIFESPARC
78207577 2794945 Dead/Cancelled
NIPPON KAYAKU KABUSHIKI KAISHA
2003-01-27
LIFESPARC
LIFESPARC
78031924 2690896 Dead/Cancelled
Lifesparc, Inc.
2000-10-23

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