Compumedics Grael 8028-0001-02

GUDID 09342451001269

Grael v2 Assembly

COMPUMEDICS LIMITED

Electroencephalograph
Primary Device ID09342451001269
NIH Device Record Keya1efe939-2e12-49c9-ba79-dbb86ded5709
Commercial Distribution StatusIn Commercial Distribution
Brand NameCompumedics Grael
Version Model NumberGrael
Catalog Number8028-0001-02
Company DUNS753750967
Company NameCOMPUMEDICS LIMITED
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au
Phone+61384207386
Emailsupport@compumedics.com.au

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109342451001269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLVStandard Polysomnograph With Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-04-27
Device Publish Date2016-11-29

On-Brand Devices [Compumedics Grael]

09342451001924Grael PSG Package
09342451001917Grael PSG starter kit
09342451001894Grael LT Package EEG5
09342451001870Grael arm adapter for SUN-S3A trolley
09342451001832Grael LT Package EEG4
09342451001825Grael EEG v2 System with EEG software
09342451001771Grael v2 System with PSG software
09342451001313Grael PSG System, no software
09342451001306Grael PSG Assembly
09342451001290Grael LT System, no software
09342451001283Grael LT Assembly
09342451001276Grael v2 System, no software
09342451001269Grael v2 Assembly
09342451001252Grael EEG v2 System - no software
09342451001245Grael cradle assembly
09342451001238Grael EEG v2 Assembly

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