Quantum Perfusion Dual Lumen Cannula 31F-V1

GUDID 18051160302694

SPECTRUM MEDICAL SRL

Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage

• Primary Device ID: 18051160302694
• NIH Device Record Key: 603864e2-defd-4b8e-92a2-26d7f1426e87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum Perfusion Dual Lumen Cannula 31F-V1
• Version Model Number: DL31F-V1
• Company DUNS: 436188505
• Company Name: SPECTRUM MEDICAL 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	18051160302694 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241248

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: 2024-07-12
• Device Publish Date: 2024-07-04

Devices Manufactured by SPECTRUM MEDICAL SRL

• 18051160302694 - Quantum Perfusion Dual Lumen Cannula 31F-V1: 2024-07-12
• 18051160302694 - Quantum Perfusion Dual Lumen Cannula 31F-V1: 2024-07-12
• 18051160302786 - Quantum SuperPAC Cardioplegia Tubing Set 1/4: 2024-07-12
• 18051160302793 - Quantum SuperPAC Cardioplegia Tubing Set 1/4: 2024-07-12
• 18051160302717 - Quantum Perfusion SuperPAC Tubing set - SP05E-AA: 2024-03-14
• 18051160301840 - Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U: 2024-01-22
• 18051160301857 - Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U: 2024-01-22
• 18051160302663 - Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors: 2024-01-22