Neurovirtual PV 2311

GUDID 00867975000288

BWMini PSG: Full-montage standard electroencephalograph device

M F Equipamentos Medicos Ltda Epp

Polysomnograph
Primary Device ID00867975000288
NIH Device Record Key55a721c4-f2e7-4bc9-81a8-af5e1fd1c1da
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeurovirtual
Version Model NumberBWMini PSG
Catalog NumberPV 2311
Company DUNS904571309
Company NameM F Equipamentos Medicos Ltda Epp
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 65 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 102 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100867975000288 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWQFull-Montage Standard Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-04-15

On-Brand Devices [Neurovirtual]

00867975000288BWMini PSG: Full-montage standard electroencephalograph device
00867975000271BWMini HST: Full-montage standard electroencephalograph device
00867975000264BWMini EEG: Full-montage standard electroencephalograph device
00867975000257BWII PSG Digital: Full-montage standard electroencephalograph device
00867975000240BWII EEG Digital: Full-montage standard electroencephalograph device
00867975000233BWIII EEG: Full-montage standard electroencephalograph device
00867975000226BWIII PSG: Full-montage standard electroencephalograph device
00867975000219BWIII EEG Plus: Full-montage standard electroencephalograph device
00867975000202BWIII PSG Plus: Full-montage standard electroencephalograph device

Trademark Results [Neurovirtual]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NEUROVIRTUAL
NEUROVIRTUAL
78922440 not registered Dead/Abandoned
Neurovirtual USA, Inc.
2006-07-05
NEUROVIRTUAL
NEUROVIRTUAL
77204897 3378310 Live/Registered
Neurovirtual USA, Inc.
2007-06-13

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