FDA.reportPublic FDA data

NA

Primary DI
00613994425041
Brand
NA
Company
MEDTRONIC, INC.
Model
HCS150
Device description
STAND HCS150 HAND CRANK
Published
2016-04-28
Public version status
Update
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
K080824000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080824000BIO-CONSOLE 560Medtronic Perfusion Systems2008-05-07DWA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994425041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994425041006139944250416139944250410613994425041

GMDN Terms#

Term, Definition table
TermDefinition
Centrifugal circulatory assist pump, manualA centrifugal pump that is manually hand cranked (rotated) by the perfusionist or operator present in order to substitute for the electrically-operated pump during a power outage. It is a specially constructed pump 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613994733658Pulmonary Wedge Pressure Catheter1500752016-06-12
00613994811639Z2Z26JR4052016-06-11
00613994813053Z2Z26EBU3552016-06-11
00643169356979Z2Z27FR40D2016-04-25
00643169356993Z2Z27AL75D2016-06-11
00643169559820Euphora™EUP1510X2016-04-25
00643169559837Euphora™EUP1512X2016-04-11
00643169559844Euphora™EUP1515X2016-04-11
00643169559851Euphora™EUP1520X2016-04-11
00643169559868Euphora™EUP2006X2016-04-11
00643169559875Euphora™EUP2010X2016-04-11
00643169559905Euphora™EUP2020X2016-04-11
00643169559912Euphora™EUP2025X2016-04-25
00643169559929Euphora™EUP2030X2016-04-11
00643169559936Euphora™EUP22506X2016-04-11
00643169559943Euphora™EUP22510X2016-04-11
00643169559950Euphora™EUP22512X2016-04-11
00643169559967Euphora™EUP22515X2016-04-11
00643169559974Euphora™EUP22520X2016-04-11
00643169559981Euphora™EUP22525X2016-04-11

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07290117830147INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
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17290117830052INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
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07290117830086INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
17290117830090INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830109INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
07290117830116INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
17290117830144INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
00850000067059Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
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