Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors

GUDID 18051160302663

SPECTRUM MEDICAL 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

• Primary Device ID: 18051160302663
• NIH Device Record Key: bae6e549-df78-47bf-b2d1-1cf6f20dd416
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors
• Version Model Number: CP37V-VT
• 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	18051160302663 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233091

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: 2024-01-22
• Device Publish Date: 2024-01-12

Devices Manufactured by SPECTRUM MEDICAL SRL

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• 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
• 18051160302663 - Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors: 2024-01-22