KIT Quantum SuperPAC Tubing Set - 200R

GUDID 28051160302509

SPECTRUM MEDICAL SRL

Cardiopulmonary bypass system blood tubing set
Primary Device ID28051160302509
NIH Device Record Key65e42897-bb55-400b-bbd5-b72910e2ca3f
Commercial Distribution StatusIn Commercial Distribution
Brand NameKIT Quantum SuperPAC Tubing Set - 200R
Version Model NumberSPC-200R
Company DUNS436188505
Company NameSPECTRUM MEDICAL SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS128051160302509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-20
Device Publish Date2024-08-12

Devices Manufactured by SPECTRUM MEDICAL SRL

08051160300709 - Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C22024-11-27
08051160300761 - Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C22024-11-27
18051160302205 - Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W2024-11-27
18051160302267 - Quantum PureFlow Cardioplegia Heat Exchanger High Flow 1/4 W2024-11-27
18051160301864 - Quantum Perfusion Blood Oxygenator VT75-E12024-11-13
18051160301871 - Quantum Perfusion Blood Oxygenator VT75-E22024-11-13
18051160302755 - Quantum SuperPAC Tubing set - SP07C-DA2024-08-20
18051160302816 - Quantum SuperPAC Tubing set - SP07C-AA2024-08-20

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