Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U

GUDID 08051160301430

QURA 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 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 ID08051160301430
NIH Device Record Key3d471fd1-eaab-46d9-a155-2a1dc15acb1d
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U
Version Model NumberVT200-C2U
Company DUNS436188505
Company NameQURA 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 Numbertrue
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
GS108051160301430 [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 Date2022-02-24
Device Publish Date2022-02-16

Devices Manufactured by QURA SRL

08051160302130 - Quantum Perfusion Capnometer Line Set2023-08-18
08051160300846 - Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors2023-07-05
18051160302144 - Quantum Perfusion Centrifugal Blood Pump CP202023-07-05
18051160302151 - Quantum PureFlow Standard Heat Exchanger Low Flow 3/82023-05-12
18051160302168 - Quantum PureFlow Standard Heat Exchanger Low Flow 1/4 M2023-05-12
18051160302175 - Quantum PureFlow Standard Heat Exchanger Low Flow 3/8 M2023-05-12
08051160301713 - Quantum Perfusion Dual Lumen Cannula 31F-VS2022-09-13
08051160301720 - Quantum Perfusion Dual Lumen Cannula 27F-VS 2022-09-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.