Compumedics Neuvo 4722-0028-01

GUDID 09342451001139

Bracket Event Button - Neuvo Base Trolley and Wall Column

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: 09342451001139
• NIH Device Record Key: 78db3acc-8925-4320-833d-3b875d9061e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compumedics Neuvo
• Version Model Number: Neuvo-Bracket Event Button
• Catalog Number: 4722-0028-01
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09342451001139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081151

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: 2016-10-26

On-Brand Devices [Compumedics Neuvo]

• 09342451001207: Cable Assembly, LTM to Amplifier , NEMO - 10m
• 09342451001184: Dual Headbox Bracket, Neuvo System Mounting Kits (AC376)
• 09342451001177: Neuvo Headbox 128Ch - Wall Column Kit
• 09342451001160: Cable - Neuvo Control Unit, 2 meters
• 09342451001153: LTM Harness Cover
• 09342451001146: Bracket - System Unit Neuvo System Mounting Kits
• 09342451001139: Bracket Event Button - Neuvo Base Trolley and Wall Column
• 09342451001122: Bracket - LTM Headbox - Neuvo System Mounting Kits
• 09342451001115: Bracket - Headbox, Neuvo System Mounting Kits
• 09342451001108: Bracket - Headbox Mount
• 09342451001092: Neuvo Headbox Assembly
• 09342451001085: Neuvo System Unit Assembly
• 09342451001078: LTM Module Assembly- Neuvo
• 09342451001061: Neuvo Headbox (Amplifier) 64 Ch - Wall Column Kit
• 09342451001054: Neuvo System Unit Assembly - no HDD
• 09342451001047: LTM Module - Neuvo
• 09342451001030: Neuvo Event Button V2
• 09342451001023: Neuvo Wall Mount Assembly
• 09342451001016: System-Neuvo Wall Mnt 64 Ch LTM