KIT Quantum SuperPAC Tubing Set - 200

GUDID 28051160302462

SPECTRUM MEDICAL SRL

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 28051160302462
• NIH Device Record Key: 6d310f37-9965-4754-854e-94e907d8124d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KIT Quantum SuperPAC Tubing Set - 200
• Version Model Number: SPC-200
• 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: true
• 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	28051160302462 [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: 2024-08-20
• Device Publish Date: 2024-08-12

Devices Manufactured by SPECTRUM MEDICAL SRL

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• 18051160303189 - Quantum SuperPAC CPB – 3/8 Venous: 2025-09-30
• 18051160303196 - Quantum SuperPAC CPB – 3/8 Venous with AV Bridge: 2025-09-30
• 18051160303202 - Quantum SuperPAC Hybrid CPB: 2025-09-30
• 18051160301796 - Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2: 2025-09-19
• 18051160302977 - Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors: 2025-09-05
• 18051160302991 - Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors: 2025-07-22