Identity
- Trade Name
- Nautilus VF ECMO Oxygentaor FDA UDI
- Generic Name
- Extracorporeal membrane oxygenator FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 58110 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 58110 FDA UDI
- Primary DI / UDI-DI
- 10850007732315 FDA UDI
- 510(k) Number
- K232767 FDA UDI
- FDA Product Code
- BYS FDA UDI
- GMDN Term
- Extracorporeal membrane oxygenator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Extracorporeal membrane oxygenator
Nautilus VF ECMO Oxygentaor by Michigan Critical Care Consultants, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K232767 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Michigan Critical Care Consultants, Inc.
Sources (1)
- FDA UDI 3c4c1867-6451-44ca-9eaf-0324c0bd2e46 35 fields · synced May 30, 2026