FDA.reportPublic FDA data

LifeSPARC

Primary DI
00814112020609
Brand
LifeSPARC
Company
CARDIACASSIST, INC.
Model
5800-1000
Device description
LifeSPARC Priming Tray Kit: LIfeSPARC Blood Pump with TandemLung Oxygenator
Published
2020-05-29
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
DTZOxygenator, Cardiopulmonary Bypass
KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
KRIAccessory Equipment, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTZOxygenator, Cardiopulmonary BypassCardiovascular2
KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller TypeCardiovascular2
KRIAccessory Equipment, Cardiopulmonary BypassCardiovascular1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153295000
K183623000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153295000TandemLung OxygenatorCardiacassist, Inc.2016-02-26DTZ
K183623000LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc.2019-07-09KFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814112020609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814112020609008141120206098141120206090814112020609

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system centrifugal pumpA device intended to be connected to a drive unit (not included) to circulate blood through the extracorporeal circuit of a non-roller type cardiopulmonary bypass system, via a centrifugal force mechanism, for gas exchange and reinfusion; it may in addition be used in extracorporeal support systems for ventricular support/circulatory assistance. It includes flow channels and a rotor driven by the system’s drive unit. This is a single-use device.

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
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
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
00814112020593LifeSPARC5800-00002019-12-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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