FDA.reportPublic FDA data

PEDIMAG BLOOD PUMP

Primary DI
07640135140634
Brand
PEDIMAG BLOOD PUMP
Company
Thoratec Switzerland GmbH
Model
201-90052
Catalog number
201-90052
Published
2014-09-20
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
07640135140634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640135140634076401351406347640135140634

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system centrifugal pumpA sterile 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 includes a spinning rotor and flow channels; the connected drive unit uses magnetism to spin the rotor; it may in addition be used in extracorporeal support systems for ventricular support/circulatory assistance. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
486066918
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640135140184CENTRIMAG® 34FR DRAINAGE (VENOUS) CANNULA KIT201-50067201-500672014-09-20
07640135140351CENTRIMAG™ TRAINING LOOP1029631029632014-09-20
07640135140405METAL LOCKING FEATURE FOR CENTRIMAG MOTOR1043261043262014-09-20
07640135140498CentriMag Pressure Cable for BD DTX Plus Transducer1043031043032014-09-20
07640135140771CENTRIMAG™ System Transporter201-50140201-501402014-09-20
07640135140603CENTRIMAG RVAS HDE KIT1043181043182014-09-20
07640135140320CONSOLE STANDOFF1043051043052014-09-20
07640135140559CONSOLE STANDOFF DISTANCE HOLDER201-52009201-520092014-09-20
07640135140788CIRCULAR OXYGENATOR BRACKET SMALL201-50141201-501412014-09-20
07640135140795CIRCULAR OXYGENATOR BRACKET MEDIUM201-50142201-501422014-09-20
07640135140801CIRCULAR OXYGENATOR BRACKET LARGE201-50143201-501432014-09-20
07640135140818SQUARE OXYGENATOR BRACKET201-50144201-501442014-09-20
07640135140191CENTRIMAG® 24FR RETURN CANNULA KIT201-50068201-500682014-09-20
07640135140696Mag Monitor Set201-90404201-904042014-09-20
07640135140399TUBING BEND RELIEF201-50126201-501262014-09-20
07640135140535THORATEC RECHARGEABLE LI-ION BATTERY201-50207201-502072014-09-20
07640135140542INTERNAL RECHARGEABLE NIMH BATTERY PACK FOR CENTRIMAG PRIMARY CONSOLE1041721041722014-09-20
07640135140627CentriMag™1029531029532014-09-20
07640135140825CMAG TRANSPORTER, SPARE PART KIT 201-50147201-501472014-09-20
07640135140467PEDIATRIC TRAINING LOOP201-50134201-501342014-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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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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
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00814112020692TandemLife LifeSPARCCARDIACASSIST, INC.KFM2020-06-01
00814112020708TandemLife LifeSPARCCARDIACASSIST, INC.KFM2020-06-01
00763000301323Affinity™ CPMEDTRONIC, INC.KFM2020-05-31