Home GUDID 00860013047702 EpiWatch
Primary DI 00860013047702
Brand EpiWatch
Company Epiwatch, Inc.
Model 1
Device description Seizure detection algorithm app for tonic clonic seizure detection, alerting and monitoring
Published 2026-03-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name POS Physiological Signal Based Seizure Monitoring System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class POS Physiological Signal Based Seizure Monitoring System Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860013047702 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860013047702 00860013047702 860013047702 0860013047702
GMDN Terms# Term, Definition table Term Definition Clinical decision management support software An application software program intended to facilitate clinical management decisions by receiving patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care information (e.g., reports, referral pathways, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, guidelines links) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. It may also be referred to as clinical decision support (CDS) software, and may be a locally-installed program, web-based, or mobile app.
Regulatory Flags# DUNS number 118597858 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08719327236086 NightWatch+ US Livassured B.V. POS 2026-01-06 00853858006379 EpiMonitor EMPATICA SRL POS 2024-08-14 00853858006386 EpiMonitor EMPATICA SRL POS 2024-08-14 00853858006102 Embrace2 EMPATICA SRL POS 2020-02-11 00853858006119 Embrace2 EMPATICA SRL POS 2020-02-11 00853858006126 Embrace2 EMPATICA SRL POS 2020-02-11 00853858006133 Embrace2 EMPATICA SRL POS 2020-02-11 00853858006140 Embrace2 EMPATICA SRL POS 2020-02-11 B481SPC15900541 AccuSense Sensitive Electrode Patch-SPC15-90054 US BRAIN SENTINEL, INC. POS 2019-11-07 B481SPC15900551 AccuSense Sensitive Electrode Patch SPC15-90055 EU BRAIN SENTINEL, INC. POS 2019-11-07 B481SPC15900580 SPEAC System Assy, Mini Monitor, EU BRAIN SENTINEL, INC. POS 2019-09-05 B481SPC15900180 SPEAC System Electrode Patch SPC15-90018 BRAIN SENTINEL, INC. POS 2019-09-04 B481SPC15900430 SPEAC System Electrode Patch-SPC15-900431 BRAIN SENTINEL, INC. POS 2019-09-04 B481SPC15900440 SPEAC System Electrode Patch SPC15-90044, EU BRAIN SENTINEL, INC. POS 2019-09-04 B481SPC15900450 SPEAC System Electrode Patch-SPC15-90045, EU BRAIN SENTINEL, INC. POS 2019-09-04 B481SPC15900570 SPEAC System Assy, Mini Monitor, US BRAIN SENTINEL, INC. POS 2019-09-04 B481SPC15900441 SPEAC System Electrode Patch SPC15-90044, EU BRAIN SENTINEL, INC. POS 2019-08-26 B481SPC15900451 SPEAC System Electrode Patch-SPC15-90045, EU BRAIN SENTINEL, INC. POS 2019-08-26 B481SPC15900181 SPEAC System Electrode Patch SPC15-90018 BRAIN SENTINEL, INC. POS 2019-08-13 B481SPC15900431 SPEAC System Electrode Patch-SPC15-900431 BRAIN SENTINEL, INC. POS 2019-08-13 B481SPC15900571 SPEAC System Assy, Mini Monitor, US BRAIN SENTINEL, INC. POS 2019-08-13 08538580061026 Embrace2 EMPATICA SRL POS 2018-11-09 08538580061194 Embrace2 EMPATICA SRL POS 2018-11-09 08538580061262 Embrace2 EMPATICA SRL POS 2018-11-09 08538580061330 Embrace2 EMPATICA SRL POS 2018-11-09 08538580061408 Embrace2 EMPATICA SRL POS 2018-11-09 B481SPC150 SPEAC System BRAIN SENTINEL, INC. POS 2017-09-01