Quantum PureFlow Centrifugal Blood Pump CP22

GUDID 28051160300604

QURA SRL

Cardiopulmonary bypass system centrifugal pump
Primary Device ID28051160300604
NIH Device Record Key768aca3e-de45-4e71-8384-e9c5064e3783
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantum PureFlow Centrifugal Blood Pump CP22
Version Model NumberCP22V-V0
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
GS108051160300600 [Primary]
GS128051160300604 [Package]
Contains: 08051160300600
Package: carton multiple box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-05
Device Publish Date2020-04-27

Devices Manufactured by QURA SRL

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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

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