Quantum Perfusion Arterial Cannula Graft

GUDID 08051160300839

QURA SRL

Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial
Primary Device ID08051160300839
NIH Device Record Key94fbeb8d-0a53-4cf3-907b-1b99fc678f6f
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantum Perfusion Arterial Cannula Graft
Version Model NumberAG08-V0
Company DUNS436188505
Company NameQURA SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
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
GS108051160300839 [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 Date2021-08-16
Device Publish Date2021-08-06

Devices Manufactured by QURA SRL

08051160300679 - Quantum Perfusion Blood Oxygenator ECC VT200-E12021-12-31
08051160300686 - Quantum Perfusion Blood Oxygenator ECC VT200-E22021-12-31
08051160300730 - Quantum Perfusion Blood Oxygenator ECC VT160-E12021-12-31
08051160300747 - Quantum Perfusion Blood Oxygenator ECC VT160-E22021-12-31
08051160300792 - Quantum Perfusion Dual Lumen Cannula 31F2021-12-28
08051160300808 - Quantum Perfusion Dual Lumen Cannula 272021-12-28
08051160300815 - Quantum Perfusion Dual Lumen Cannula 24F2021-12-28
08051160300822 - Quantum Perfusion Single Lumen Cannula 22F 2021-12-28

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