g.HIamp 7091US

GUDID EBCI7091US0

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.

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 Multiple physiological signal amplifier
Primary Device IDEBCI7091US0
NIH Device Record Keyc61f84e7-e65f-4408-b503-828cec218945
Commercial Distribution StatusIn Commercial Distribution
Brand Nameg.HIamp
Version Model Number32-Channel Amplifier
Catalog Number7091US
Company DUNS300916041
Company Nameg.tec medical engineering GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at
Phone+437251222400
Emailsupport@gtec.at

Device Dimensions

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Operating and Storage Conditions

Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEBCI7091US0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWLAmplifier, Physiological Signal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-07
Device Publish Date2020-03-30

On-Brand Devices [g.HIamp]

EBCI7092US0The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity
EBCI7091US0The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity
EBCI7003US0The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity
EBCI70030The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity
EBCI7002US0The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity
EBCI70020The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity
EBCI7001US0The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity
EBCI70010The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity

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