Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U

GUDID 08051160301423

QURA SRL

Extracorporeal membrane oxygenator
Primary Device ID08051160301423
NIH Device Record Key9b97860f-a515-4598-a29d-eb2b5355c069
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U
Version Model NumberVT200-C1U
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
GS108051160301423 [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

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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

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