FDA.reportPublic FDA data

Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors

Primary DI
18051160302991
Brand
Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors
Company
SPECTRUM MEDICAL SRL
Model
CP22V-NG
Published
2025-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

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
K250326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250326000Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)Spectrum Medical S.R.L.2025-06-24KFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18051160302991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805116030299118051160302991

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
436188505
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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18051160302878Quantum SuperPAC Tubing Set - SP05E-BBSP05E-BB2026-05-27
18051160300614Quantum Perfusion Centrifugal Blood Pump CP37CP37V-V02026-05-21
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
18051160301710Quantum Perfusion Dual Lumen Cannula 31F-VSDL31F-VS2026-05-21
18051160302137Quantum Perfusion Capnometer Line SetCAP-SP12026-05-21
28051160301564Quantum PureFlow KIT CPC - Barbed Connector AdaptorCONN-HX12026-05-21
28051160301571Quantum PureFlow KIT CPC - Hansen Connector AdaptorCONN-HX22026-05-21
18051160302762Quantum Perfusion Blood Oxygenator VT200-E3VT200-E32026-04-07
18051160302779Quantum Perfusion Blood Oxygenator VT160-E3VT160-E32026-04-07
18051160303363Quantum Perfusion Blood Oxygenator VT75-E3VT75-E32026-04-07
18051160303349Quantum SuperPAC Adapter Tubing Set 3/8CGSP8-B22026-03-31
18051160302212Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WHX22V-S0W2026-03-18
18051160303141Quantum SuperPAC CPB – 3/8 VenousSPC160A-D32026-01-30
18051160303325Quantum SuperPAC CPB – 3/8 Venous with AV BridgeSPC160A-D42026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18051160300614Quantum Perfusion Centrifugal Blood Pump CP37SPECTRUM MEDICAL SRLKFM2026-05-21
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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
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