FDA.reportPublic FDA data

LifeSPARC

Primary DI
00814112020593
Brand
LifeSPARC
Company
CARDIACASSIST, INC.
Model
5800-0000
Device description
LifeSPARC blood pump kit with accessories
Published
2019-12-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
KRIAccessory Equipment, Cardiopulmonary Bypass
QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller TypeCardiovascular2
KRIAccessory Equipment, Cardiopulmonary BypassCardiovascular1
QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) UseCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814112020593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814112020593008141120205938141120205930814112020593

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18003737421tl.regulatory@livanova.com
+1412-963-7770tl.regulatory@livanova.com

Regulatory Flags#

DUNS number
948683941
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
06974762682221LifemotionLifemotion Medical Technology Co., Ltd.KRI2026-06-05
06974762681101LifemotionLifemotion Medical Technology Co., Ltd.KRI2026-06-02
18051160300614Quantum Perfusion Centrifugal Blood Pump CP37SPECTRUM MEDICAL SRLKFM2026-05-21
18051160302137Quantum Perfusion Capnometer Line SetSPECTRUM MEDICAL SRLKRI2026-05-21
28051160301564Quantum PureFlow KIT CPC - Barbed Connector AdaptorSPECTRUM MEDICAL SRLKRI2026-05-21
28051160301571Quantum PureFlow KIT CPC - Hansen Connector AdaptorSPECTRUM MEDICAL SRLKRI2026-05-21
08052595517144HOLDEREUROSETS SRLKRI2026-05-05
08052595517458HOLDEREUROSETS SRLKRI2026-05-05
08052595517465HOLDEREUROSETS SRLKRI2026-05-05
07290117830079INSPIRA CARTQTREX Quantum Ltd.KRI2024-11-10
00814112020586LifeSPARCCARDIACASSIST, INC.QNR2023-02-24
00699753450967Capiox® iCP Centrifugal PumpTerumo Cardiovascular Systems CorporationKFM2022-06-17
00699753450974Capiox® iCP Centrifugal PumpTerumo Cardiovascular Systems CorporationKFM2022-06-17
00814112020906LifeSPARCCARDIACASSIST, INC.QNR2022-05-10
07640135140276CentriMag™Thoratec CorporationKRI2022-03-29
07640135140283CentriMag™Thoratec CorporationKRI2022-03-29
07640135140412CentriMag™Thoratec CorporationKRI2022-03-29
07640135140429CentriMag™Thoratec CorporationKRI2022-03-29
07640135140436CentriMag™Thoratec CorporationKRI2022-03-29
07640135140443CentriMag™Thoratec CorporationKRI2022-03-29
07640135140481CentriMag™Thoratec CorporationKRI2022-03-29
07640135140566CentriMag™Thoratec CorporationKRI2022-03-29
00763000134532Affinity™MEDTRONIC, INC.KFM2020-10-20
00763000134556Affinity™MEDTRONIC, INC.KFM2020-10-20
00763000134563Affinity™MEDTRONIC, INC.KFM2020-10-20
00814112020692TandemLife LifeSPARCCARDIACASSIST, INC.KFM2020-06-01
00814112020692TandemLife LifeSPARCCARDIACASSIST, INC.QNR2020-06-01
00814112020708TandemLife LifeSPARCCARDIACASSIST, INC.KFM2020-06-01
00814112020708TandemLife LifeSPARCCARDIACASSIST, INC.QNR2020-06-01
00814112020609LifeSPARCCARDIACASSIST, INC.KFM2020-05-29