Quantum SuperPAC Tubing Set - SP01E-AA

GUDID 08051160301461

QURA SRL

Cardiopulmonary bypass system tubing set
Primary Device ID08051160301461
NIH Device Record Key25f9276e-1ba1-4cad-87ce-c3ff16d88180
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantum SuperPAC Tubing Set - SP01E-AA
Version Model NumberSP01E-AA
Company DUNS436188505
Company NameQURA SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
GS108051160301461 [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 Date2022-06-15
Device Publish Date2022-06-07

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