FDA.reportPublic FDA data

Affinity™

Primary DI
20763000134536
Brand
Affinity™
Company
MEDTRONIC, INC.
Model
AP40
Device description
PUMP AP40 AFFINITY CP CENTRIFUGAL NC
Published
2020-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

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
20763000134536PackageGS14In Commercial Distribution
00763000134532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300013453620763000134536
00763000134532007630001345327630001345320763000134532

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Special Storage Condition, Specify00Store the product at room temperature.
Storage Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
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
00763000134556Affinity™MEDTRONIC, INC.KFM2020-10-20
00763000134563Affinity™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
00814112020609LifeSPARCCARDIACASSIST, INC.KFM2020-05-29