Cumulus Functional Neurophysiology Platform CN-T5H

GUDID 05061027610011

Cumulus EEG Headset and Mobile Application

CUMULUS NEUROSCIENCE LIMITED

Electroencephalographic electrode cap, reusable

• Primary Device ID: 05061027610011
• NIH Device Record Key: 3b1714c1-aba5-4759-ab86-42809b7150da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cumulus Functional Neurophysiology Platform
• Version Model Number: CN-T5H
• Catalog Number: CN-T5H
• Company DUNS: 220568006
• Company Name: CUMULUS NEUROSCIENCE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: +442892646600
• Email: info@cumulusneuro.com
• Phone: +442892646600
• Email: info@cumulusneuro.com
• Phone: +442892646600
• Email: info@cumulusneuro.com
• Phone: +442892646600
• Email: info@cumulusneuro.com
• Phone: +442892646600
• Email: info@cumulusneuro.com
• Phone: +442892646600
• Email: info@cumulusneuro.com
• Phone: +442892646600
• Email: info@cumulusneuro.com
• Phone: +442892646600
• Email: info@cumulusneuro.com
• Phone: +442892646600
• Email: info@cumulusneuro.com
• Phone: +442892646600
• Email: info@cumulusneuro.com
• Phone: +442892646600
• Email: info@cumulusneuro.com
• Phone: +442892646600
• Email: info@cumulusneuro.com
• Phone: +442892646600
• Email: info@cumulusneuro.com
• Phone: +442892646600
• Email: info@cumulusneuro.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05061027610011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221963

FDA Product Code

• GWQ: Full-Montage Standard Electroencephalograph

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: 2024-06-13
• Device Publish Date: 2024-06-05