FDA.reportPublic FDA data

KIT Quantum SuperPAC Tubing Set - 200R

Primary DI
28051160302509
Brand
KIT Quantum SuperPAC Tubing Set - 200R
Company
SPECTRUM MEDICAL SRL
Model
SPC-200R
Published
2024-08-12
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
28051160302509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2805116030250928051160302509

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
436188505
Device count
1
Kit
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
18051160302175Quantum PureFlow Standard Heat Exchanger Low Flow 3/8 MHX11W-S2M2023-05-04
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00824846024767NAMEDTRONIC, INC.DWF2026-10-26
00803622104091Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104107Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104114Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104121Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104138Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104145Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104152Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104169Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622105692Venous cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-23
00803622104176Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104183Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104190Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104206Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104213Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104220Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104237Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104244Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104251Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104268Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104275Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104282Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104299Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104305Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104312Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104329Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104336Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104343Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104350Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17
00803622104367Arterial cardiopulmonary bypass cannulaLIVANOVA USA, INC.DWF2015-07-17