FDA.reportPublic FDA data

Quantum Perfusion Hybrid System

Primary DI
18051160302724
Brand
Quantum Perfusion Hybrid System
Company
SPECTRUM MEDICAL SRL
Model
HR04V-A0
Published
2024-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DTNReservoir, Blood, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTNReservoir, Blood, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241206000Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L.2024-07-18DTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18051160302724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805116030272418051160302724

GMDN Terms#

Term, Definition table
TermDefinition
Cardiotomy reservoirA device intended to be integrated within an extracorporeal circuit to collect, store, and filter blood typically during a cardiopulmonary bypass procedure; it does not include additional functional components such as an oxygenator. It is typically a hardshell or soft, bag-like container with connectors designed to trap micro-particles and air bubbles for a period of time (e.g., 6 hours) and hold a reserve supply of blood; some types may also defoam. 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
18051160302175Quantum PureFlow Standard Heat Exchanger High Flow 3/8 MHX11W-S2M2023-05-04
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

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