FDA.reportPublic FDA data

Quantum PureFlow KIT CPC - Hansen Connector Adaptor

Primary DI
28051160301571
Brand
Quantum PureFlow KIT CPC - Hansen Connector Adaptor
Company
SPECTRUM MEDICAL SRL
Model
CONN-HX2
Published
2026-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRIAccessory Equipment, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRIAccessory Equipment, Cardiopulmonary BypassCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28051160301571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2805116030157128051160301571

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system heat exchanger, reusableA device consisting of a heat exchanging system intended to be used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device for the purposes of cardiopulmonary bypass intervention or treatment. This device will typically be a module of a cardiopulmonary bypass system whereby it receives thermal transfer fluid at a specific temperature from a system heating/cooling unit. This is a reusable device.

Regulatory Flags#

DUNS number
436188505
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08051160300617Quantum Perfusion Centrifugal Blood Pump CP37CP37V-V02020-04-27
18051160300614Quantum Perfusion Centrifugal Blood Pump CP37CP37V-V02026-05-21
08051160301171Quantum PureFlow Standard Heat Exchanger High Flow 3/8HX55W-S02022-02-16
08051160301188Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4HX22W-S02022-02-16
08051160301195Quantum PureFlow Standard Heat Exchanger Low Flow 3/16HX11W-S02022-02-16
08051160301201Quantum PureFlow Standard Heat Exchanger Low Flow 1/4HX11W-S12022-02-16
08051160301218Quantum PureFlow Cardioplegia Heat Exchanger High Flow 1/4HX32W-C02022-02-16
08051160301225Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 3/16HX22W-C02022-02-16
08051160301232Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 1/4HX22W-C12022-02-16
08051160301249Quantum PureFlow Cardioplegia Heat Exchanger High Flow 1/4 - PLHX32W-C42022-02-16
08051160301256Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 3/16 - PLHX22W-C42022-02-16
08051160301263Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 1/4 - PLHX22W-C52022-02-16
18051160302175Quantum PureFlow Standard Heat Exchanger High Flow 3/8 MHX11W-S2M2023-05-04
18051160302878Quantum SuperPAC Tubing Set - SP05E-BBSP05E-BB2026-05-27
18051160300676Quantum Perfusion Blood Oxygenator VT200-E1VT200-E12026-05-21
18051160300706Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2VT200-C22026-05-21
18051160300768Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2VT160-C22026-05-21
18051160300799Quantum Perfusion Dual Lumen Cannula 31FDL31F-V02026-05-21
18051160300805Quantum Perfusion Dual Lumen Cannula 27FDL27F-V02026-05-21
18051160300812Quantum Perfusion Dual Lumen Cannula 24FDL24F-V02026-05-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08033178102292DAC CardiotomySORIN GROUP ITALIA SRLKRI2023-10-24
08033178102384ExchangerSORIN GROUP ITALIA SRLKRI2023-10-24
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08033178109857D100/D101SORIN GROUP ITALIA SRLKRI2023-10-24
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