Quantum Perfusion Dual Lumen Cannula 29F-V1

GUDID 08051160301744

QURA SRL

Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous

• Primary Device ID: 08051160301744
• NIH Device Record Key: a8458683-22c3-4e85-99ed-2154292775cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum Perfusion Dual Lumen Cannula 29F-V1
• Version Model Number: DL29F-V1
• 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: false
• 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	08051160301744 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221353

FDA Product Code

• DWF: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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: 2022-09-13
• Device Publish Date: 2022-09-05

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
• 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