REMI 20039

GUDID 00860011072461

REMI Server

Epitel, Inc.

Electroencephalographic monitoring system

• Primary Device ID: 00860011072461
• NIH Device Record Key: 0b3e2300-c624-4afd-a54a-0cc3466833d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REMI
• Version Model Number: ab3.x.x
• Catalog Number: 20039
• Company DUNS: 808401157
• Company Name: Epitel, Inc.
• 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: 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: (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 Identifiers

Device Issuing Agency	Device ID
GS1	00860011072461 [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
• 00860011072485: REMI Server