REMI Vigilenz 20104

GUDID 00860005388189

Bioelectrical signal analysis software

Primary Device ID	00860005388189
NIH Device Record Key	50373930-a17c-47ca-badb-8fa4984b6528
Commercial Distribution Status	In Commercial Distribution
Brand Name	REMI Vigilenz
Version Model Number	1.x.x
Catalog Number	20104
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

Device Issuing Agency	Device ID
GS1	00860005388189 [Primary]

OMB	Automatic Event Detection Software For Full-Montage Electroencephalograph

Steralize Prior To Use	false
Device Is Sterile	false

00860005388134 - REMI	2024-10-14 REMI Wireless EEG Sensor
00860005388110 - REMI	2024-10-14 REMI EEG Monitoring Software
00860005388158 - REMI	2024-10-14 REMI-Cloud
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

Mark Image Registration \| Serial	Company Trademark Application Date
REMI VIGILENZ 98246840 not registered Live/Pending	Epitel, Inc. 2023-10-30