Neurovirtual

Basic Information

• Brand Name: Neurovirtual
• Primary DI: 00850008393297
• Version / Model: Maxxi Position Sensor
• Catalog Number: SI
• Company Name: NEUROVIRTUAL USA, INC.
• Labeler DUNS: 791140622
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-06
• Public Version: 1
• Public Version Date: 2020-08-14
• Public Version Status: New
• Public Device Record Key: 9037d7f1-05b2-4b23-816a-b3f01dfebae8

Device Description

The Maxxi Position Sensor is intended for use with the polysomnograph system to acquire the body position of adult patients during sleep studies

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LEL	Device, Sleep Assessment	Neurology	882.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33843	Polysomnograph	A mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850008393297	GS1

Premarket Submissions

Submission Number	Supplement Number
K191492	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 40 – 104 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity