FDA.reportPublic FDA data

Affinity™ CP

Primary DI
00763000301323
Brand
Affinity™ CP
Company
MEDTRONIC, INC.
Model
AP40AST
Device description
ADAPTER AP40AST AFFINITY CP WW 31L
Published
2020-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132712000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132712000AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTERMedtronic, Inc.2013-11-19KFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000301323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000301323007630003013237630003013230763000301323

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height28Millimeter
Outer Diameter94Millimeter
Weight315Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106.3 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Avoid storing the adapter in direct sunlight
Special Storage Condition, Specify00Do not store at extremes of temperature and humidity
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00This way up
Storage Environment Atmospheric Pressure70 KiloPascal106.3 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Serial number
true

Other Devices From This Company#

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00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
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00613994964120Sones™ Brachial9907072016-06-05
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00199150080694NABB12V43R12026-05-23

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
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20763000134550Affinity™MEDTRONIC, INC.KFM2020-10-20
20763000134567Affinity™MEDTRONIC, INC.KFM2020-10-20
00814112020692TandemLife LifeSPARCCARDIACASSIST, INC.KFM2020-06-01
00814112020708TandemLife LifeSPARCCARDIACASSIST, INC.KFM2020-06-01
00814112020609LifeSPARCCARDIACASSIST, INC.KFM2020-05-29