Neurovirtual SI1873

GUDID 00850008393020

Gold cup electrodes 60" length, (5 electrodes/pack)

NEUROVIRTUAL USA, INC.

Analytical non-scalp cutaneous electrode
Primary Device ID00850008393020
NIH Device Record Keye2b455d0-6d1a-4131-b84b-7b6539a91e31
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeurovirtual
Version Model NumberMaxxi Gold Snap Electrode 60"
Catalog NumberSI1873
Company DUNS791140622
Company NameNEUROVIRTUAL USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850008393020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-04
Device Publish Date2019-11-26

On-Brand Devices [Neurovirtual]

00850008393280The Maxxi Snore Sensor is a device intended to acquire snore bursts
00850008393273The Maxxi Snore Sensor is a device intended to acquire snore bursts
00850008393266piezo-electric element covered by Thermoplastic elastomers 2 ft lenght
00850008393259Polysomnograph BWMini HST Compass
00850008393242Polysomnograph BWMini HST
00850008393235Electroencephalograph BWMini EEG
00850008393228Polysomnograph BWMini PSG
00850008393211Polysomnograph and Electroencephalograph BWIII PSG Plus
00850008393204Polysomnograph BWIII PSG
00850008393198Electroencephalograph BWIII EEG Plus
00850008393181Electroencephalograph BWIII EEG
00850008393174Electroencephalograph BWIII Basics
00850008393167Maxxi Rip System length: .3ft is a device intended to capture respiratory effort from a patient
00850008393150Maxxi Rip System length: 7ft is a device intended to capture respiratory effort from a patient a
00850008393143Maxxi Rip Abdomen Interface 7ft is a device intended to capture respiratory effort from a patien
00850008393136Maxxi Rip Abdomen Interface 3ft is a device intended to capture respiratory effort from a patien
00850008393129Maxxi Rip Thorax Interface 3ft is a device intended to capture respiratory effort from a patient
00850008393112Maxxi Rip Thorax Interface 7ft is a device intended to capture respiratory effort from a patient
00850008393105Maxxi Rip Adjustable inductive belt is a device intended to capture respiratory effort from a pa
00850008393099Maxxi Rip XX-Large inductive belt is a device intended to capture respiratory effort from a pati
00850008393082Maxxi Rip X-Large inductive belt is a device intended to capture respiratory effort from a patie
00850008393075Maxxi Rip Large inductive belt is a device intended to capture respiratory effort from a patient
00850008393068Maxxi Rip pediatric inductive belt is a device intended to capture respiratory effort from a pat
00850008393051Maxxi Rip Infant inductive belt is a device intended to capture respiratory effort from a patien
00850008393044Gold cup electrodes 48" length, (5 electrodes/pack)
00850008393037Gold cup electrodes 48" length, (5 electrodes/pack)
00850008393020Gold cup electrodes 60" length, (5 electrodes/pack)
00850008393013Gold cup electrodes 96" length, (5 electrodes/pack)
00850008393006Gold cup electrodes 96" length, (5 electrodes/pack)
00867975000295Gold cup electrodes 60" length, (5 electrodes/pack)
00850008393297The Maxxi Position Sensor is intended for use with the polysomnograph system to acquire the body
00850008393310Disposable AgCl cup electrodes 96" length, (5 electrodes/pack)
00850008393303Disposable AgCl cup electrodes 60" length, (5 electrodes/pack)
00850008393341The Maxxi Flow Sensor is a thermocouple intended to acquire the respiratory signals
00850008393334The Maxxi Flow Sensor is a thermocouple intended to acquire the respiratory signals
00850008393327The Maxxi Flow Sensor is a thermocouple intended to acquire the respiratory signal
00850008393365Reusable AgCl cup electrodes 96" length, (5 electrodes/pack)
00850008393358Reusable AgCl cup electrodes 60" length, (5 electrodes/pack)
00850008393396Maxxi Cannula is a two-pronged device used to acquire breathing pressure to sleep testing device
00850008393389Maxxi Cannula is a two-pronged device used to acquire breathing pressure to sleep testing device
00850008393372Maxxi Cannula is a two-pronged device used to acquire breathing pressure to sleep testing 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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