Identity
- Trade Name
- MC3 Nautilus ECMO Oxygenator FDA UDI
- Generic Name
- Extracorporeal membrane oxygenator FDA UDI
- Device Name
- Nautilus ECMO oxygenators are diffusion membrane oxygenators 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. FDA UDI
- Model / Reference
- 48145E FDA UDI
- Description
- Nautilus ECMO oxygenators are diffusion membrane oxygenators 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. FDA UDI
Identifiers
- Catalog Number
- 48145E FDA UDI
- Primary DI / UDI-DI
- 10854916006901 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
Category: Extracorporeal membrane oxygenator
MC3 Nautilus ECMO Oxygenator by Michigan Critical Care Consultants, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extracorporeal membrane oxygenator.
- INSPIRE — SORIN GROUP ITALIA SRL · Class II
- Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir — Terumo Cardiovascular Systems Corporation · Class II
- AMG PMP INFANT STERILE — EUROSETS SRL · Class II
- Affinity Fusion® — MEDTRONIC, INC. · Class II
- CAPIOX — Terumo Corp. · Class II
- CAPIOX®RX — Terumo Corp. · Class II
- Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. — Terumo Cardiovascular Systems Corporation · Class II
- CAPIOX®FX — Terumo Corp. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Michigan Critical Care Consultants, Inc.
Sources (1)
- FDA UDI cadd0bdd-4770-4ac5-a7ac-736af2109633 34 fields · synced May 31, 2026