FDA.reportPublic FDA data

Quantum Perfusion Capnometer Line Set

Primary DI
18051160302137
Brand
Quantum Perfusion Capnometer Line Set
Company
SPECTRUM MEDICAL SRL
Model
CAP-SP1
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
18051160302137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805116030213718051160302137

GMDN Terms#

Term, Definition table
TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
18051160303332Quantum SuperPAC Hybrid CPBSPC160A-D52026-01-30
18051160303264Quantum SuperPAC CP Support U - High FlowSPW200C-B1U2025-12-30
18051160303271Quantum SuperPAC CP Support U- Low FlowSPW075C-C1U2025-12-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
28051160301564Quantum PureFlow KIT CPC - Barbed Connector AdaptorSPECTRUM MEDICAL SRLKRI2026-05-21
28051160301571Quantum PureFlow KIT CPC - Hansen Connector AdaptorSPECTRUM MEDICAL SRLKRI2026-05-21
08052595517144HOLDEREUROSETS SRLKRI2026-05-05
08052595517458HOLDEREUROSETS SRLKRI2026-05-05
08052595517465HOLDEREUROSETS SRLKRI2026-05-05
05060434424457QuantumSPECTRUM MEDICAL LIMITEDKRI2026-03-20
05060434424532QuantumSPECTRUM MEDICAL LIMITEDKRI2026-03-09
05415067034441CentriMag™Thoratec CorporationKRI2026-02-02
00850054036629Cardio Quip VivaCart Short Infusion Pole with Removable HooksCARDIOQUIP, LLCKRI2025-10-28
08034013785489HOLDEREUROSETS SRLKRI2025-02-19
07290117830079INSPIRA CARTINSPIRA TECHNOLOGIES OXY B.H.N LTDKRI2024-11-10
17290117830076INSPIRA CARTINSPIRA TECHNOLOGIES OXY B.H.N LTDKRI2024-11-10
10850007732353VitalFlow CaddyMICHIGAN CRITICAL CARE CONSULTANTS, INC.KRI2024-09-19
05060434423962QuantumSPECTRUM MEDICAL LIMITEDKRI2023-12-22
05060434423979QuantumSPECTRUM MEDICAL LIMITEDKRI2023-12-22
05060434423986Quantum SPECTRUM MEDICAL LIMITEDKRI2023-12-22
25060434423966QuantumSPECTRUM MEDICAL LIMITEDKRI2023-12-22
25060434423973QuantumSPECTRUM MEDICAL LIMITEDKRI2023-12-22
25060434423980Quantum SPECTRUM MEDICAL LIMITEDKRI2023-12-22
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08033178101622Vanguard, CSC 14 and HSCSORIN GROUP ITALIA SRLKRI2023-10-24
08033178102292DAC CardiotomySORIN GROUP ITALIA SRLKRI2023-10-24
08033178102384ExchangerSORIN GROUP ITALIA SRLKRI2023-10-24
08033178103428HemoconcentratorSORIN GROUP ITALIA SRLKRI2023-10-24
08033178109857D100/D101SORIN GROUP ITALIA SRLKRI2023-10-24
08033178109864D130/D131 KIDS Arterial FilterSORIN GROUP ITALIA SRLKRI2023-10-24
08033178111959InspireSORIN GROUP ITALIA SRLKRI2023-10-24
08033178111966InspireSORIN GROUP ITALIA SRLKRI2023-10-24
08033178112970InspireSORIN GROUP ITALIA SRLKRI2023-10-24
08033178112987InspireSORIN GROUP ITALIA SRLKRI2023-10-24