g.Nautilus PRO 5720PRO

GUDID EBCI5720PRO0

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

• Primary Device ID: EBCI5720PRO0
• NIH Device Record Key: e08d0edf-6939-474a-a9b2-6fa5cfa28dbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: g.Nautilus PRO
• Version Model Number: 8 FLEXIBLE channels
• Catalog Number: 5720PRO
• Company DUNS: 300916041
• Company Name: g.tec medical engineering GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +437251222400
• Email: support@gtec.at
• Phone: +437251222400
• Email: support@gtec.at
• Phone: +437251222400
• Email: support@gtec.at
• Phone: +437251222400
• Email: support@gtec.at
• Phone: +437251222400
• Email: support@gtec.at
• Phone: +437251222400
• Email: support@gtec.at
• Phone: +437251222400
• Email: support@gtec.at
• Phone: +437251222400
• Email: support@gtec.at
• Phone: +437251222400
• Email: support@gtec.at
• Phone: +437251222400
• Email: support@gtec.at
• Phone: +437251222400
• Email: support@gtec.at
• Phone: +437251222400
• Email: support@gtec.at
• Phone: +437251222400
• Email: support@gtec.at

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EBCI5720PRO0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171669

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-26
• Device Publish Date: 2021-04-16

On-Brand Devices [g.Nautilus PRO]

• EBCI5220PRO0: The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
• EBCI5212PRO0: The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
• EBCI5211PRO0: The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
• EBCI5210PRO0: The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
• EBCI5201PRO0: The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
• EBCI5200PRO0: The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
• EBCI5120PRO0: The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
• EBCI5112PRO0: The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
• EBCI5111PRO0: The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
• EBCI5110PRO0: The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
• EBCI5101PRO0: The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
• EBCI5100PRO0: The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
• EBCI5720PRO0: The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
• EBCI5710PRO0: The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
• EBCI5700PRO0: The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit