Nautilus VF ECMO Oxygentaor

Basic Information

• Brand Name: Nautilus VF ECMO Oxygentaor
• Primary DI: 10850007732315
• Version / Model: 58110
• Catalog Number: 58110
• Company Name: MICHIGAN CRITICAL CARE CONSULTANTS, INC.
• Labeler DUNS: 806687406
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-19
• Public Version: 1
• Public Version Date: 2024-09-27
• Public Version Status: New
• Public Device Record Key: 3c4c1867-6451-44ca-9eaf-0324c0bd2e46

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYS	Oxygenator, Long Term Support Greater Than 6 Hours	Cardiovascular	870.4100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17643	Extracorporeal membrane oxygenator	A device designed for the extracorporeal diffusion of oxygen into blood across a gas-permeable membrane during a cardiopulmonary bypass or extracorporeal membrane oxygenation procedure. It includes a membrane that separates a thin layer of blood from the oxygenating gas; oxygen diffuses from the gas compartment into the blood, while carbon dioxide diffuses from the blood through the membrane and is flushed out of the oxygenator by the oxygen flow. The device may include an integrated heat exchanger, arterial filter, or cardiotomy/venous reservoir. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10850007732315	GS1

Premarket Submissions

Submission Number	Supplement Number
K232767	000