AccessGUDID - DEVICE: g.Nautilus PRO (EBCI5100PRO0)

GUDID

Device Identifier (DI) Information

Brand Name: g.Nautilus PRO
Version or Model: 32-Channel
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5100PRO
Company Name: g.tec medical engineering GmbH

Primary DI Number: EBCI5100PRO0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 300916041 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
32521	Multiple physiological signal amplifier	An electronic device that increases current, voltage, or power to adjust the signal level and impedance between two or more medical devices transmitting physiological signals; or the device has the capability of being used for more than a single application, such as electroencephalography (EEG), evoked potential, polysomnography (sleep analysis) and general polygraphy.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXY	Electrode, Cutaneous
GWL	Amplifier, Physiological Signal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171669	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 25 and 65 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 45 Degrees Celsius
Handling Environment Temperature: between 5 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Channel Number 32

Device Record Status

Public Device Record Key: 179e1e81-647b-455b-9503-48c74eb79541
Public Version Date: December 02, 2020
Public Version Number: 4
DI Record Publish Date: November 23, 2017