Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2

GUDID 08051160300709

SPECTRUM MEDICAL SRL

Extracorporeal membrane oxygenator

• Primary Device ID: 08051160300709
• NIH Device Record Key: d09dd382-a4d9-41c5-89e8-3b6651f77bb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2
• Version Model Number: VT200-C2
• 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	08051160300709 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212341

FDA Product Code

• DTZ: Oxygenator, 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: 2024-11-27
• Device Publish Date: 2024-11-19

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