Compumedics 7028-0006-02

GUDID 09342451001849

Grael event button V2_Green

COMPUMEDICS LIMITED

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

• Primary Device ID: 09342451001849
• NIH Device Record Key: 0c5ae9d5-41d5-4471-93fc-c88f052c9e67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compumedics
• Version Model Number: 7028-0006-02
• Catalog Number: 7028-0006-02
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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: true

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09342451001849 [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: 2016-12-22

On-Brand Devices [Compumedics]

• 09342451001863: Assembly - Grael Trolley
• 09342451001856: Photic Stimulator
• 09342451001849: Grael event button V2_Green
• 09342451001467: Adult silicone soft tip finger probe-oximeter-1m