AccessGUDID - DEVICE: g.HIamp (EBCI70010)

GUDID

Device Identifier (DI) Information

Brand Name: g.HIamp
Version or Model: 80-Channel Amplifier
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7001
Company Name: g.tec medical engineering GmbH

Primary DI Number: EBCI70010
Issuing Agency: HIBCC
Commercial Distribution End Date: January 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 300916041 *Terms of Use

Device Description: The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children, infants and animals.

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 [?]
K123255	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 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Channel Number 80

Device Record Status

Public Device Record Key: 060f85b9-92ed-4be6-904d-2ac7847a5aff
Public Version Date: January 31, 2019
Public Version Number: 5
DI Record Publish Date: April 12, 2017