Compumedics Grael 9028-0009-01

GUDID 09342451001313

Grael PSG System, no software

COMPUMEDICS LIMITED

Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph

• Primary Device ID: 09342451001313
• NIH Device Record Key: 07007c03-9a97-4bb2-9088-39e0c6ec96b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compumedics Grael
• Version Model Number: Grael PSG
• Catalog Number: 9028-0009-01
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage 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	09342451001313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093223

FDA Product Code

• OLV: Standard Polysomnograph With 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