AccessGUDID - DEVICE: g.USBamp (EBCI0216US0)

GUDID

Device Identifier (DI) Information

Brand Name: g.USBamp
Version or Model: USB Biosignal Amplifier
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0216US
Company Name: g.tec medical engineering GmbH

Primary DI Number: EBCI0216US0
Issuing Agency: HIBCC
Commercial Distribution End Date: April 08, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 300916041 *Terms of Use
Previous DI: EBCI02160

Device Description: The g.USBamp is inteded to measuring, recording and analysis of electrical activity of the brain (EEG) and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for the EEG.

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
GWL	Amplifier, Physiological Signal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060803	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
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 25 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Channel Number 16

Device Record Status

Public Device Record Key: 7cbef0cf-65da-4a47-bcad-7267fbe393b0
Public Version Date: February 21, 2020
Public Version Number: 4
DI Record Publish Date: November 23, 2017