Quantum Perfusion Dual Lumen Cannula 31F-V1

GUDID 18051160302694

SPECTRUM MEDICAL SRL

Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
Primary Device ID18051160302694
NIH Device Record Key603864e2-defd-4b8e-92a2-26d7f1426e87
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantum Perfusion Dual Lumen Cannula 31F-V1
Version Model NumberDL31F-V1
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
GS118051160302694 [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 Date2024-07-12
Device Publish Date2024-07-04

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