Quantum Perfusion SuperPAC Tubing set - SP05E-AA

GUDID 18051160302717

SPECTRUM MEDICAL SRL

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• Primary Device ID: 18051160302717
• NIH Device Record Key: 8b603300-1e49-4447-83d0-ba0f1de762e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum Perfusion SuperPAC Tubing set - SP05E-AA
• Version Model Number: SP05E-AA
• Company DUNS: 436188505
• Company Name: SPECTRUM MEDICAL SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	18051160302717 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213540

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: 2024-03-14
• Device Publish Date: 2024-03-06

Devices Manufactured by SPECTRUM MEDICAL SRL

• 18051160302717 - Quantum Perfusion SuperPAC Tubing set - SP05E-AA: 2024-03-14
• 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