REMI 20110

GUDID 00860011072454

REMI Ambulatory Patient Starter Kit

Epitel, Inc.

Electroencephalographic monitoring system

• Primary Device ID: 00860011072454
• NIH Device Record Key: 5d8516cf-2ea9-4742-aac9-b5afa6fbbd70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REMI
• Version Model Number: 20110
• Catalog Number: 20110
• Company DUNS: 808401157
• Company Name: Epitel, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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: (801)497-6297
• Email: support@epitel.com
• Phone: (801)497-6297
• Email: support@epitel.com
• Phone: (801)497-6297
• Email: support@epitel.com
• Phone: (801)497-6297
• Email: support@epitel.com
• Phone: (801)497-6297
• Email: support@epitel.com
• Phone: (801)497-6297
• Email: support@epitel.com
• Phone: (801)497-6297
• Email: support@epitel.com
• Phone: (801)497-6297
• Email: support@epitel.com
• Phone: (801)497-6297
• Email: support@epitel.com
• Phone: (801)497-6297
• Email: support@epitel.com
• Phone: (801)497-6297
• Email: support@epitel.com
• Phone: (801)497-6297
• Email: support@epitel.com
• Phone: (801)497-6297
• Email: support@epitel.com
• Phone: (801)497-6297
• Email: support@epitel.com
• Phone: (801)497-6297
• Email: support@epitel.com

Device Dimensions

• Length: 1 Inch
• Width: 1 Inch
• Depth: 0.25 Inch
• Length: 1 Inch
• Width: 1 Inch
• Depth: 0.25 Inch
• Length: 1 Inch
• Width: 1 Inch
• Depth: 0.25 Inch
• Length: 1 Inch
• Width: 1 Inch
• Depth: 0.25 Inch
• Length: 1 Inch
• Width: 1 Inch
• Depth: 0.25 Inch
• Length: 1 Inch
• Width: 1 Inch
• Depth: 0.25 Inch
• Length: 1 Inch
• Width: 1 Inch
• Depth: 0.25 Inch
• Length: 1 Inch
• Width: 1 Inch
• Depth: 0.25 Inch
• Length: 1 Inch
• Width: 1 Inch
• Depth: 0.25 Inch
• Length: 1 Inch
• Width: 1 Inch
• Depth: 0.25 Inch
• Length: 1 Inch
• Width: 1 Inch
• Depth: 0.25 Inch
• Length: 1 Inch
• Width: 1 Inch
• Depth: 0.25 Inch
• Length: 1 Inch
• Width: 1 Inch
• Depth: 0.25 Inch
• Length: 1 Inch
• Width: 1 Inch
• Depth: 0.25 Inch
• Length: 1 Inch
• Width: 1 Inch
• Depth: 0.25 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011072454 [Primary]

FDA Product Code

• OMC: Reduced- 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: 2024-08-14
• Device Publish Date: 2024-08-06

On-Brand Devices [REMI]

• 08600053881650: REMI Tablet
• 00860011072430: REMI Daily Sticker Kit
• 00860011072423: REMI Sticker
• 00860005388172: REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Use Module
• 00860005388165: REMI Wireless EEG Sensor
• 00860011072461: REMI Server
• 00860011072454: REMI Ambulatory Patient Starter Kit
• 00860011072447: REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Use Module
• 00860011072416: REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Startup Module
• 00860005388158: REMI-Cloud
• 00860005388110: REMI EEG Monitoring Software
• 00860005388134: REMI Wireless EEG Sensor