Quantum SuperPAC CPB – 3/8 Venous with AV Bridge

GUDID 18051160303196

SPECTRUM MEDICAL SRL

Cardiopulmonary bypass system blood tubing set

• Primary Device ID: 18051160303196
• NIH Device Record Key: 4a80d199-73bb-40c2-92e9-1365f6ed75e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum SuperPAC CPB – 3/8 Venous with AV Bridge
• Version Model Number: SPC200A-D4
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	18051160303196 [Primary]

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: 2025-09-30
• Device Publish Date: 2025-09-22

Devices Manufactured by SPECTRUM MEDICAL SRL

• 18051160303264 - Quantum SuperPAC CP Support U - High Flow: 2026-01-07
• 18051160303271 - Quantum SuperPAC CP Support U- Low Flow: 2026-01-07
• 18051160303295 - Quantum SuperPAC Cardioplegia - Master Follower: 2026-01-07
• 18051160303301 - Quantum SuperPAC Cardioplegia - Quick System: 2026-01-07
• 18051160303318 - Quantum SuperPAC Cardioplegia - Clamp System: 2026-01-07
• 18051160302236 - Quantum PureFlow Standard Heat Exchanger Low Flow 3/16 W: 2025-12-31
• 18051160302274 - Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 3/16 W: 2025-12-31
• 18051160303066 - Quantum SuperPAC CPB - 1/2 Venous: 2025-09-30