Axon 100161

GUDID 09413000078459

EEG Biofeedback (Neurofeedback) Kit - Large includes Axon EEG headset - Large, Tablet with Axon Neurofeedback Software Application

EXSURGO LIMITED

Psychophysiological biofeedback system

• Primary Device ID: 09413000078459
• NIH Device Record Key: ef4fa65e-dd61-4e76-80e6-7ae590a28729
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axon
• Version Model Number: Large
• Catalog Number: 100161
• Company DUNS: 594916540
• Company Name: EXSURGO LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com
• Phone: +6492183583
• Email: info@exsurgo.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	09413000078459 [Primary]

FDA Product Code

• HCC: Device, Biofeedback

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-23
• Device Publish Date: 2021-08-13

On-Brand Devices [Axon]

• 09413000078459: EEG Biofeedback (Neurofeedback) Kit - Large includes Axon EEG headset - Large, Tablet with Axon
• 09413000078442: Neurofeedback Kit - Medium includes Axon EEG headset - Medium, Tablet with Axon Neurofeedback So
• 09413000078435: Neurofeedback Kit - Small includes Axon EEG headset - Small, Tablet with Axon Neurofeedback Soft
• 09413000078428: EEG Headset - Large
• 09413000078411: EEG Headset - Small
• 09413000077094: EEG Headset - Medium
• 09413000078510: Neurofeedback Software Application for Android
• 09413000107500: Axon Neurofeedback software Application for iOS