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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 Position Sensor is intended for use with the polysomnograph system to acquire the body position of adult patients during sleep studies FDA UDI
Model / Reference
Maxxi Position Sensor FDA UDI
Description
The Maxxi Position Sensor is intended for use with the polysomnograph system to acquire the body position of adult patients during sleep studies FDA UDI

Identifiers

Catalog Number
SI FDA UDI
Primary DI / UDI-DI
00850008393297 FDA UDI
510(k) Number
K191492 FDA UDI
FDA Product Code
LEL FDA UDI
GMDN Term
Polysomnograph FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

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

Similar devices

Also classified as Polysomnograph.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neurovirtual Usa, Inc.

Sources (1)

  • FDA UDI 9037d7f1-05b2-4b23-816a-b3f01dfebae8 36 fields · synced May 30, 2026