Compumedics Neuvo 8022-0004-01

GUDID 09342451001085

Neuvo System Unit Assembly

COMPUMEDICS LIMITED

Electroencephalograph

• Primary Device ID: 09342451001085
• NIH Device Record Key: edfc7750-3463-4a09-81dd-636dfa92c474
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compumedics Neuvo
• Version Model Number: Neuvo System Unit Assembly
• Catalog Number: 8022-0004-01
• 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: 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

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	09342451001085 [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: 2016-10-27

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