Nautilus VF Oxygenator Cable

FDA UDI

Class II (US FDA UDI)

by Michigan Critical Care Consultants, Inc.

Identity

Trade Name: Nautilus VF Oxygenator Cable FDA UDI
Generic Name: Extracorporeal membrane oxygenator FDA UDI
Device Name: Power and data cable for the Nautilus VF ECMO Oxygenator FDA UDI
Model / Reference: 58130 FDA UDI
Description: Power and data cable for the Nautilus VF ECMO Oxygenator FDA UDI

Identifiers

Catalog Number: 48150 FDA UDI
Primary DI / UDI-DI: 10850007732322 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Extracorporeal membrane oxygenator

Nautilus VF Oxygenator Cable by Michigan Critical Care Consultants, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Extracorporeal membrane oxygenator.

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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

Cleared under the same submission

K232767 also covers:

Nautilus VF ECMO Oxygentaor — MICHIGAN CRITICAL CARE CONSULTANTS, INC.

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 90e6f32b-c158-4cf2-b6a8-5eb6576e189f 35 fields · synced May 30, 2026