FDA.reportPublic FDA data

REVOLUTION

Primary DI
08033178104777
Brand
REVOLUTION
Company
SORIN GROUP ITALIA SRL
Model
REVOLUTION
Published
2014-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KFMPUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller TypeCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011835000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011835000COBE REVOLUTIONCobe Cardiovascular, Inc.2002-02-12KFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38033178104778PackageGS18In Commercial Distribution
08033178104777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3803317810477838033178104778
08033178104777080331781047778033178104777

GMDN Terms#

Term, Definition table
TermDefinition
Centrifugal circulatory assist pump, electricA mains electricity (AC-powered), specially constructed, centrifugal pump that is used to maintain blood circulation in heart failure. It is used to provide circulatory assistance (support of the blood circulation when the heart fails) to the patient due to his/her dependence upon artificial assistance in order to maintain the body's heart function. This dependence will be due to the lack of the heart's ability to function normally. The pump may be used during open heart surgery and postoperatively for a short period to assist the heart in regaining function.

Regulatory Flags#

DUNS number
442126587
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033178102933DHF02 HEMOCONCENTRATOR2015-07-15
08033178102940DHF06 HEMOCONCENTRATOR2015-07-15
08033178109062CSC 14CSC14 + PURGE LINE2015-07-10
08033178112253INSPIRE6M2015-05-13
08033178112277INSPIRE6F M2015-05-13
08033178112284INSPIRE8F M2015-05-13
08033178112291INSPIREHVR2015-05-13
08033178112307INSPIREHVR DUAL2015-05-13
08033178112352INSPIRE6 PH.I.S.I.O.2015-05-13
08033178112369INSPIRE8 PH.I.S.I.O.2015-05-13
08033178112376INSPIRE6F PH.I.S.I.O.2015-05-13
08033178112383INSPIRE8F PH.I.S.I.O.2015-05-13
08033178112390INSPIRE6 DUAL PH.I.S.I.O.2015-05-13
08033178112406INSPIRE8 DUAL PH.I.S.I.O.2015-05-13
08033178112413INSPIRE6F DUAL PH.I.S.I.O.2015-05-13
08033178112420INSPIRE8F DUAL PH.I.S.I.O.2015-05-13
08033178113014INSPIRESVR 12002017-03-29
08033178113182INSPIRE7 M2019-08-28
08033178113212INSPIRE72019-08-28
08033178113236INSPIRE7 DUAL2019-08-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18051160300614Quantum Perfusion Centrifugal Blood Pump CP37SPECTRUM MEDICAL SRLKFM2026-05-21
00643169845114NAMEDTRONIC, INC.KFM2025-12-22
18051160302977Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated SensorsSPECTRUM MEDICAL SRLKFM2025-08-28
18051160302991Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors SPECTRUM MEDICAL SRLKFM2025-07-14
18051160302663Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated SensorsSPECTRUM MEDICAL SRLKFM2024-01-12
08051160300846Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated SensorsSPECTRUM MEDICAL SRLKFM2023-06-27
18051160302144Quantum Perfusion Centrifugal Blood Pump CP20SPECTRUM MEDICAL SRLKFM2023-06-27
05415067036414CentriMag™Thoratec CorporationKFM2023-05-17
05060434422132QuantumSPECTRUM MEDICAL LIMITEDKFM2022-10-25
05060434422149QuantumSPECTRUM MEDICAL LIMITEDKFM2022-10-25
00699753450967Capiox® iCP Centrifugal PumpTerumo Cardiovascular Systems CorporationKFM2022-06-17
00699753450974Capiox® iCP Centrifugal PumpTerumo Cardiovascular Systems CorporationKFM2022-06-17
50699753450962Capiox® iCP Centrifugal PumpTerumo Cardiovascular Systems CorporationKFM2022-06-17
50699753450979Capiox® iCP Centrifugal PumpTerumo Cardiovascular Systems CorporationKFM2022-06-17
08051160300624Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated SensorsSPECTRUM MEDICAL SRLKFM2021-11-15
04058863076355HLS SetMaquet Cardiopulmonary AGKFM2021-07-29
04058863078861HLS SetMaquet Cardiopulmonary AGKFM2021-07-29
04058863080383HLS SetMaquet Cardiopulmonary AGKFM2021-07-29
00814321020438FloPumpMovair, Inc.KFM2021-03-12
00814321020445FloPumpMovair, Inc.KFM2021-03-12
00860001797947Abiomed Breethe OXY-1 SystemBreethe, Inc.KFM2020-11-30
00763000134532Affinity™MEDTRONIC, INC.KFM2020-10-20
00763000134556Affinity™MEDTRONIC, INC.KFM2020-10-20
00763000134563Affinity™MEDTRONIC, INC.KFM2020-10-20
20763000134536Affinity™MEDTRONIC, INC.KFM2020-10-20
20763000134550Affinity™MEDTRONIC, INC.KFM2020-10-20
20763000134567Affinity™MEDTRONIC, INC.KFM2020-10-20
00814112020692TandemLife LifeSPARCCARDIACASSIST, INC.KFM2020-06-01
00814112020708TandemLife LifeSPARCCARDIACASSIST, INC.KFM2020-06-01
00763000301323Affinity™ CPMEDTRONIC, INC.KFM2020-05-31