FDA.reportPublic FDA data

LifeSPARC

Primary DI
00814112020586
Brand
LifeSPARC
Company
CARDIACASSIST, INC.
Model
1000-0765
Device description
Controller Battery
Published
2023-02-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWAControl, Pump Speed, Cardiopulmonary Bypass
QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWAControl, Pump Speed, Cardiopulmonary BypassCardiovascular2
QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) UseCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183623000
K211830000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183623000LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc.2019-07-09KFM
K211830000LifeSPARC SystemCardiacassist, Inc.2022-11-15QNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814112020586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814112020586008141120205868141120205860814112020586

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system centrifugal pump drive unitA mains electricity (AC-powered) device that powers and controls the speed of a disposable cardiovascular bypass system centrifugal pump, to which it is connected, for the circulation of blood through the extracorporeal circuit for gas exchange and reinfusion. This device drives the centrifugal rotor of the disposable centrifugal pump using magnetism.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18003737421tl.regulatory@livanova.com
+14129637770tl.regulatory@livanova.com

Regulatory Flags#

DUNS number
948683941
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814112020166PROTEK Duo5140-46292015-10-10
00814112020319ProtekDuo5140-51312016-09-23
00814112020067TandemHeart5140-62212015-10-10
00814112020098TandemHeart5140-62172015-10-10
00814112020104TandemHeart5130-17175130-17172015-10-10
00814112020111TandemHeart5130-17155130-17152015-10-10
00814112020449ProtekSolo5140-60245140-60242017-01-27
00814112020456ProtekDuo5100-14262017-05-22
00814112020623LifeSPARC5900-00012020-05-27
00814112020630LifeSPARC5900-00022020-05-27
00814112020692TandemLife LifeSPARC5840-24172020-06-01
00814112020906LifeSPARC5900-00125900-00122022-05-10
00814112020609LifeSPARC5800-10002020-05-29
00814112020685TandemLife LifeSPARC5840-00002020-05-29
00814112020753TandemLung LifeSPARC5830-29162020-05-29
00814112020760TandemLung LifeSPARC5830-31182020-05-29
00814112020777TandemLung LifeSPARC5830-36312020-05-29
00814112020814LifeSPARC5800-10012020-05-29
00814112020562LifeSPARC5900-00002019-12-18
00814112020579LifeSPARC5900-00032019-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640135140153CentriMag™Thoratec CorporationDWA2026-02-19
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07290117830055INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830062INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830093INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830147INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830048INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830052INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830069INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830086INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830090INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830109INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830116INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830144INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
10850007732346VitalFlow Centrifugal Pump MICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-20
10850007732247VitalFlow ConsoleMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
10850007732254VitalFlow Motor DriveMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
10850007732261VitalFlow Emergency HandcrankMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
10850007732278VitalFlow Flow and Bubble Sensor, 2mMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
10850007732285VitalFlow Power Cord NEMA-5-15, 3mMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
10850007732292VitalFlow Power Cord CEE 7/7, 2.5mMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
10850007732308VitalFlow Power Cord 12 V DC, 3mMICHIGAN CRITICAL CARE CONSULTANTS, INC.QNR2024-09-19
00850000067059Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067066Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067073Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067080Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067097Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067103Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067110Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067127Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11