Quantum SuperPAC Cardioplegia Tubing Set 1/4 - CGSP8-B1

GUDID 18051160303097

SPECTRUM MEDICAL SRL

Cardioplegia solution administration kit

• Primary Device ID: 18051160303097
• NIH Device Record Key: 6b58b641-e9e0-426a-90cf-b209520127f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum SuperPAC Cardioplegia Tubing Set 1/4 - CGSP8-B1
• Version Model Number: CGSP8-B1
• 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: 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	18051160303097 [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: 2025-04-28
• Device Publish Date: 2025-04-18

Devices Manufactured by SPECTRUM MEDICAL SRL

• 18051160303097 - Quantum SuperPAC Cardioplegia Tubing Set 1/4 - CGSP8-B1: 2025-04-28
• 18051160303097 - Quantum SuperPAC Cardioplegia Tubing Set 1/4 - CGSP8-B1: 2025-04-28
• 08051160300709 - Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2: 2024-11-27
• 08051160300761 - Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2: 2024-11-27
• 18051160302205 - Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W: 2024-11-27
• 18051160302267 - Quantum PureFlow Cardioplegia Heat Exchanger High Flow 1/4 W: 2024-11-27
• 18051160301864 - Quantum Perfusion Blood Oxygenator VT75-E1: 2024-11-13
• 18051160301871 - Quantum Perfusion Blood Oxygenator VT75-E2: 2024-11-13
• 18051160302755 - Quantum SuperPAC Tubing set - SP07C-DA: 2024-08-20