Quantum PureFlow Centrifugal Blood Pump CP37

GUDID 28051160300611

QURA SRL

Cardiopulmonary bypass system centrifugal pump
Primary Device ID28051160300611
NIH Device Record Keya7ee15b0-5c81-4d5d-b86c-ff8d3efdb145
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantum PureFlow Centrifugal Blood Pump CP37
Version Model NumberCP37V-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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108051160300617 [Primary]
GS128051160300611 [Package]
Contains: 08051160300617
Package: Multiple carton 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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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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