Nautilus VF ECMO Oxygentaor 58110

GUDID 10850007732315

The Nautilus VF ECMO Oxygenator is a diffusion polymethylpentene (PMP) membrane oxygenator with BalanceTM Biosurface used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Blood enters the device and passes through both the heat exchange membrane, where temperature is adjusted, and the gas transfer membrane, where oxygen is added and carbon dioxide is removed. The device contains integrated sensors. The following measured parameters can be transmitted to the VitalFlow ECMO Console through the Nautilus VF Oxygenator Cable: inlet pressure, inlet oxygen saturation, outlet pressure, outlet oxygen saturation, and outlet blood temperature. The difference between the inlet and outlet pressure, delta pressure, is calculated and also transmitted.

MICHIGAN CRITICAL CARE CONSULTANTS, INC.

Extracorporeal membrane oxygenator

• Primary Device ID: 10850007732315
• NIH Device Record Key: 3c4c1867-6451-44ca-9eaf-0324c0bd2e46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nautilus VF ECMO Oxygentaor
• Version Model Number: 58110
• Catalog Number: 58110
• Company DUNS: 806687406
• Company Name: MICHIGAN CRITICAL CARE CONSULTANTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850007732315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232767

FDA Product Code

• BYS: Oxygenator, Long Term Support Greater Than 6 Hours

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: 2024-09-27
• Device Publish Date: 2024-09-19

Devices Manufactured by MICHIGAN CRITICAL CARE CONSULTANTS, INC.

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• 10850007732261 - VitalFlow Emergency Handcrank: 2024-09-27 Emergency handcrank for the VitalFlow Centrifugal Pump
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• 10850007732285 - VitalFlow Power Cord NEMA-5-15, 3m: 2024-09-27 AC Power Cord (US Type A, NEMA-5-15, 3m) for VitalFlow Console
• 10850007732292 - VitalFlow Power Cord CEE 7/7, 2.5m: 2024-09-27 AC Power Cord (EU Type F, CEE 7/7, 2.5m) for VitalFlow Console
• 10850007732308 - VitalFlow Power Cord 12 V DC, 3m: 2024-09-27 DC Power Cord (12 V DC, 3m) for VitalFlow Console