AccessGUDID - DEVICE: Neurovirtual (00867975000240)

GUDID

Device Identifier (DI) Information

Brand Name: Neurovirtual
Version or Model: BWII EEG Digital
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PV 1652
Company Name: M F Equipamentos Medicos Ltda Epp

Primary DI Number: 00867975000240
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 904571309 *Terms of Use

Device Description: BWII EEG Digital: Full-montage standard electroencephalograph device

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
11467	Electroencephalograph	An electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.	Active	false
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWQ	Full-Montage Standard Electroencephalograph
OLV	Standard Polysomnograph With Electroencephalograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062533	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -40 and 65 Degrees Celsius
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 102 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 102 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5d8976cf-a17b-43f8-985a-6aa3eccc207e
Public Version Date: November 28, 2022
Public Version Number: 4
DI Record Publish Date: April 15, 2016