Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U

GUDID 18051160301857

SPECTRUM MEDICAL SRL

Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator Extracorporeal membrane oxygenator
Primary Device ID18051160301857
NIH Device Record Keyf0a0bd13-c772-444f-9790-babc3d210c44
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U
Version Model NumberVT75-C2U
Company DUNS436188505
Company NameSPECTRUM MEDICAL SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS118051160301857 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTZOxygenator, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-22
Device Publish Date2024-01-12

Devices Manufactured by SPECTRUM MEDICAL SRL

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18051160301840 - Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U2024-01-22
18051160301857 - Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U2024-01-22
18051160301857 - Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U2024-01-22
18051160302663 - Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors2024-01-22

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