Epilog

GUDID 08600053881278

Single-use continuous EEG monitor

Epitel, Inc.

Electroencephalography telemetric monitoring system

• Primary Device ID: 08600053881278
• NIH Device Record Key: 7c013c3f-0576-4dd9-913b-8912815ddca7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epilog
• Version Model Number: E001
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08600053881032 [Primary]
GS1	08600053881278 [Package]; Contains: 08600053881032; Package: [4 Units]; In Commercial Distribution
GS1	08600053881414 [Package]; Contains: 08600053881032; Package: [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203827

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: 2022-01-10
• Device Publish Date: 2022-01-01

Devices Manufactured by Epitel, Inc.

• 00860011072416 - REMI: 2024-08-14 REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Startup Module
• 00860011072447 - REMI: 2024-08-14 REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Use Module
• 00860011072454 - REMI: 2024-08-14 REMI Ambulatory Patient Starter Kit
• 00860011072461 - REMI: 2024-08-14 REMI Server
• 00860005388165 - REMI: 2024-03-19 REMI Wireless EEG Sensor
• 00860005388189 - REMI Vigilenz: 2024-03-19 REMI Vigilenz AI for Event Detection
• 00860005388172 - REMI: 2023-11-27 REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Use Module
• 00860011072423 - REMI: 2023-11-27 REMI Sticker