Neurovirtual

FDA UDI

Class II (US FDA UDI)

by Neurovirtual Usa, Inc.

Identity

Trade Name: Neurovirtual FDA UDI
Generic Name: Polysomnograph FDA UDI
Device Name: The Maxxi Flow Sensor is a thermocouple intended to acquire the respiratory signals FDA UDI
Model / Reference: Maxxi Flow Sensor 7ft Key connector FDA UDI
Description: The Maxxi Flow Sensor is a thermocouple intended to acquire the respiratory signals FDA UDI

Identifiers

Catalog Number: SI1776 FDA UDI
Primary DI / UDI-DI: 00850008393334 FDA UDI
510(k) Number: K201495 FDA UDI
FDA Product Code: MNR FDA UDI
GMDN Term: Polysomnograph FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.2375 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

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Polysomnograph

Neurovirtual by Neurovirtual Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K201495 also covers:

Neurovirtual — NEUROVIRTUAL USA, 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: Neurovirtual Usa, Inc.

Sources (1)

FDA UDI f00c79cb-c63d-4e8d-a83d-2026f3e655b8 36 fields · synced May 30, 2026