g.Nautilus PRO 5100PRO

GUDID EBCI5100PRO0

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

• Primary Device ID: EBCI5100PRO0
• NIH Device Record Key: 179e1e81-647b-455b-9503-48c74eb79541
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: g.Nautilus PRO
• Version Model Number: 32-Channel
• Catalog Number: 5100PRO
• 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
• Phone: +437251222400
• Email: support@gtec.at

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 65 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
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 65 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
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 65 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
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 65 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
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 65 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
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 65 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
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 65 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
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 65 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
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 65 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
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 65 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
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 65 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
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 65 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
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 65 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	EBCI5100PRO0 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-23

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
• EBCI5730PRO0: The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit