Quantum Perfusion Hybrid System

GUDID 18051160302724

SPECTRUM MEDICAL SRL

Cardiotomy reservoir

• Primary Device ID: 18051160302724
• NIH Device Record Key: 779d21c2-507f-4236-8695-029dd8fbc4d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum Perfusion Hybrid System
• Version Model Number: HR04V-A0
• 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	18051160302724 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241206

FDA Product Code

• DTN: Reservoir, Blood, 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: 2024-08-14
• Device Publish Date: 2024-08-06

Devices Manufactured by SPECTRUM MEDICAL SRL

• 18051160303066 - Quantum SuperPAC CPB - 1/2 Venous: 2025-09-30
• 18051160303134 - Quantum SuperPAC CPB – 1/2 Venous with AV Bridge: 2025-09-30
• 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