Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors

GUDID 08051160300846

QURA SRL

Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump

• Primary Device ID: 08051160300846
• NIH Device Record Key: b4a717b5-a324-4b9a-b0fd-cb3f1079551a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
• Version Model Number: CP20V-VT
• Company DUNS: 436188505
• Company Name: QURA SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08051160300846 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220842

FDA Product Code

• KFM: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-05
• Device Publish Date: 2023-06-27

Devices Manufactured by QURA SRL

• 08051160302130 - Quantum Perfusion Capnometer Line Set: 2023-08-18
• 08051160300846 - Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors: 2023-07-05
• 08051160300846 - Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors: 2023-07-05
• 18051160302144 - Quantum Perfusion Centrifugal Blood Pump CP20: 2023-07-05
• 18051160302151 - Quantum PureFlow Standard Heat Exchanger Low Flow 3/8: 2023-05-12
• 18051160302168 - Quantum PureFlow Standard Heat Exchanger Low Flow 1/4 M: 2023-05-12
• 18051160302175 - Quantum PureFlow Standard Heat Exchanger Low Flow 3/8 M: 2023-05-12
• 08051160301713 - Quantum Perfusion Dual Lumen Cannula 31F-VS: 2022-09-13
• 08051160301720 - Quantum Perfusion Dual Lumen Cannula 27F-VS: 2022-09-13