Compumedics Grael 9028-0001-02

GUDID 09342451001276

Grael v2 System, no software

COMPUMEDICS LIMITED

Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph

• Primary Device ID: 09342451001276
• NIH Device Record Key: d00f464e-2fed-4108-90ab-ef8d2e8f5094
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compumedics Grael
• Version Model Number: Grael
• Catalog Number: 9028-0001-02
• Company DUNS: 753750967
• Company Name: COMPUMEDICS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au
• Phone: +61384207386
• Email: support@compumedics.com.au

Operating and Storage Conditions

• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09342451001276 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093223

FDA Product Code

• GWQ: Full-Montage Standard Electroencephalograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-04-27
• Device Publish Date: 2016-11-29

On-Brand Devices [Compumedics Grael]

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