FDA.reportPublic FDA data

CAPIOX® SP PUMP

Primary DI
04987350706119
Brand
CAPIOX® SP PUMP
Company
TERUMO CORPORATION
Model
CX*SP45
Device description
CAPIOX® SP PUMP
Published
2015-07-23
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

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54987350706114PackageGS110In Commercial Distribution
04987350706119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5498735070611454987350706114
04987350706119049873507061194987350706119

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature1 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Fragile
Special Storage Condition, Specify00Keep away from rain.
Special Storage Condition, Specify00Keep away from sunlight.
Special Storage Condition, Specify00This way up.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-521-2818cvscustomerservice@terumomedic
1-800-521-2818cvscustomerservice@terumomedical.com

Regulatory Flags#

DUNS number
690543319
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987350700025OPTITORQUE40-5011RH*5TIG110A2016-09-09
04987350700049OPTITORQUE40-5012RH*5TIG210A2016-09-09
04987350700063OPTITORQUE40-5021RH*5BL3520A2016-09-09
04987350700087OPTITORQUE40-5022RH*5BL4020A2016-09-09
04987350700100OPTITORQUE40-5030RH*5SP0061A2016-09-09
04987350700124OPTITORQUE40-5031RH*5AP5561A2016-09-09
04987350700148OPTITORQUE40-5040RH*5SL3500A2016-09-09
04987350700162OPTITORQUE40-5041RH*5SL4000A2016-09-09
04987350700186OPTITORQUE40-5042RH*5SL5000A2016-09-09
04987350700209OPTITORQUE40-5043RH*5JR3500A2016-09-09
04987350700223OPTITORQUE40-5044RH*5JR4000A2016-09-09
04987350700247OPTITORQUE40-5045RH*5JR5000A2016-09-09
04987350700261OPTITORQUE40-5050RH*5BPIR00A2016-09-09
04987350700285OPTITORQUE40-5060RH*5SAL100A2016-09-09
04987350700308OPTITORQUE40-5061RH*5SAL200A2016-09-09
04987350700322OPTITORQUE40-6011RH*6TIG110A2016-09-09
04987350700346OPTITORQUE40-6012RH*6TIG210A2016-09-09
04987350700360OPTITORQUE40-6021RH*6BL3520A2016-09-09
04987350700384OPTITORQUE40-6022RH*6BL4020A2016-09-09
04987350700407OPTITORQUE40-6030RH*6SP0061A2016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
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00763000134532Affinity™MEDTRONIC, INC.KFM2020-10-20
00763000134556Affinity™MEDTRONIC, INC.KFM2020-10-20
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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