FDA.reportPublic FDA data

Quantum SuperPAC Tubing Set - SP06E-BB

Primary DI
18051160303240
Brand
Quantum SuperPAC Tubing Set - SP06E-BB
Company
SPECTRUM MEDICAL SRL
Model
SP06E-BB
Published
2025-10-17
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
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213540000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213540000Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia SetQura S.R.L2022-05-20DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18051160303240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805116030324018051160303240

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system blood tubing setA collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.

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
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
18051160303332Quantum SuperPAC Hybrid CPBSPC160A-D52026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18051160302878Quantum SuperPAC Tubing Set - SP05E-BBSPECTRUM MEDICAL SRLDWF2026-05-27
08033178019620Aortic Root cannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178019637Aortic Root cannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178019644Vessel CannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178019651Vessel CannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178019668Vessel CannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178019675Vessel CannulaSORIN GROUP ITALIA SRLDWF2026-03-06
08033178017190Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017206Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017213Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017220Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017237Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017244Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017251Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017268Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017275Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017312Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178018074Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178018098Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178018104Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019026Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019033Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019040Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019057Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019064Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019071Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019088Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019095Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019101Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019118Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11