FDA.reportPublic FDA data

NA

Primary DI
00763000244873
Brand
NA
Company
MEDTRONIC, INC.
Model
560A
Device description
MOTOR 560A EXTERNAL DRIVE SC SPCTRM PLX
Published
2020-05-07
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
DWAControl, pump speed, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWAControl, Pump Speed, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191077000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191077000Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive MotorMedtronic, Inc.2019-08-27KFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000244873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000244873007630002448737630002448730763000244873

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system centrifugal pump drive unitA mains electricity (AC-powered) device that powers and controls the speed of a disposable cardiovascular bypass system centrifugal pump, to which it is connected, for the circulation of blood through the extracorporeal circuit for gas exchange and reinfusion. This device drives the centrifugal rotor of the disposable centrifugal pump using magnetism.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius66 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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23
00199150080700NABB11E27R32026-05-23
00199150081004NABB11J58R82026-05-23
00199150081011NABB12T50R32026-05-23
00199150081035NABB7E31R342026-05-22
00199150081042NA12D63R22026-05-22
00199150081066NA4J31R12026-05-23
00199150081707NABB11J59R92026-05-22
00199150081714NABB11U73R22026-05-23
00199150081738NABB11J16R32026-05-22
00199150081745NA9M68R12026-05-23
00199150082902NABB12W52R2026-05-22
00613994963819Sones™ C0087202016-06-05
00613994963833NIH™0087622016-07-24
00613994963840NIH™0087632016-06-10
00613994963987Sones™ Brachial0077702016-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850000067141Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2025-08-26
07290117830055INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830062INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830093INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830147INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830048INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830052INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830069INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830086INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830090INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830109INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830116INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830144INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
00850000067059Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067066Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067073Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067080Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067097Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067103Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067110Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067127Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
04897102200065Anivia SG1000 Pump ConsoleAsia Pacific Medical Technology Development Company LimitedDWA2024-09-11
05415067036414CentriMag™Thoratec CorporationDWA2023-05-17
00763000301347NAMEDTRONIC, INC.DWA2023-03-18
00814112020586LifeSPARCCARDIACASSIST, INC.DWA2023-02-24
00814112020906LifeSPARCCARDIACASSIST, INC.DWA2022-05-10
04033817902782CP5LivaNova Deutschland GmbHDWA2021-05-14
10860001797968OXY-1 SystemBreethe, Inc.DWA2020-12-02
00860001797961OXY-1 SystemBreethe, Inc.DWA2020-12-02