g.Nautilus PRO 5111PRO

GUDID EBCI5111PRO0

The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.

g.tec medical engineering GmbH

Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier Multiple physiological signal amplifier
Primary Device IDEBCI5111PRO0
NIH Device Record Keyd46d7589-dee8-4376-8e6c-3330dee73416
Commercial Distribution StatusIn Commercial Distribution
Brand Nameg.Nautilus PRO
Version Model Number16-Channel-mB
Catalog Number5111PRO
Company DUNS300916041
Company Nameg.tec medical engineering GmbH
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at

Device Dimensions

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Operating and Storage Conditions

Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEBCI5111PRO0 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-23

On-Brand Devices [g.Nautilus PRO]

EBCI5220PRO0The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5212PRO0The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5211PRO0The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5210PRO0The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5201PRO0The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5200PRO0The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5120PRO0The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5112PRO0The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5111PRO0The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5110PRO0The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5101PRO0The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5100PRO0The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5720PRO0The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5710PRO0The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5700PRO0The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit

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