FDA.reportPublic FDA data

REMI Vigilenz

Primary DI
00860005388189
Brand
REMI Vigilenz
Company
Epitel, Inc.
Model
1.x.x
Catalog number
20104
Device description
REMI Vigilenz AI for Event Detection
Published
2024-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMBAutomatic Event Detection Software For Full-Montage ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005388189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005388189008600053881898600053881890860005388189

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical signal analysis softwareA software program intended to acquire, process, store and analyse biological electrical signals, both in real-time and delayed time, for diagnostic applications. The signals are typically provided by electrophysiological recording/monitoring [e.g., electromyography (EMG), electroencephalography (EEG), evoked potentials (EP), bioelectrical impedance analysis (BIA)]. It may be installed in the recording/monitoring device, personal computer, or data network server. It is neither intended for continuous bedside nor intraoperative monitoring, and is not dedicated to hearing analysis.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(801)497-6297support@epitel.com

Regulatory Flags#

DUNS number
808401157
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860005388103REMIE001-200472022-12-16
00860011072478REMI200642025-03-07
00860013649203REMI201832025-03-07
00860011072492REMI201852025-02-10
00860011072485REMIp4.x.x200392024-11-25
00860005388110REMI2.3.02022-12-16
00860005388158REMI2.32022-12-16
00860011072416REMI2.x.x.x200162024-08-06
00860011072447REMI2.x.x.x200162024-08-06
00860011072454REMI20110201102024-08-06
00860011072461REMIab3.x.x200392024-08-06
00860005388165REMI201092024-03-11
00860011072423REMI200152023-11-17
00860011072430REMI201272023-11-17
00860005388172REMI1.x.x.x2023-11-17
00860005388127REMIR001-200532022-12-16
00860005388134REMIE001-200472022-12-16
08600053881032EpilogE0012022-01-01
08600053881650REMIR0012022-01-01
08600053881278EpilogE0012022-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850056774017NeuroMatchLVIS CORPORATIONOMB2026-05-12
05060941990018AutoscoreHolberg Eeg ASOMB2026-01-28
09120109830269encevisAIT Austrian Institute of Technology GmbHOMB2025-08-05
00850056774000NeuroMatchLVIS CORPORATIONOMB2025-04-04
00869732000166Persyst 15 EEG Review and Analysis SoftwarePersyst Development CorpOMB2023-07-24
09120109830122encevisAIT Austrian Institute of Technology GmbHOMB2022-07-15
00382830058506NatusXLTEKOMB2021-10-07
00382830007443NatusXLTEKOMB2021-10-07
00851420007052Pocket EEG DeviceCERIBELL, INC.OMB2021-08-02
00382830058209NatusXLTEKOMB2021-04-20
00382830058216NatusXLTEKOMB2021-04-20
00382830058575NatusXLTEKOMB2021-04-20
09120109830078encevisAIT Austrian Institute of Technology GmbHOMB2021-01-11
00382830008020NatusXLTEKOMB2019-11-27
00382830010924NatusXLTEKOMB2019-11-27
00869732000128Persyst 14 Review and Analysis SoftwarePersyst Development CorpOMB2019-04-08
00869732000135Persyst Mobile App Persyst Development CorpOMB2019-04-08
00869732000142Persyst Mobile AppPersyst Development CorpOMB2019-04-08
00851420007045Pocket EEG Device, EEG Recording Viewer SoftwareCERIBELL, INC.OMB2018-03-28
00382830022231XLTEKXLTEKOMB2016-10-17
00382830002493NatusXLTEKOMB2016-09-13
00382830002516NatusXLTEKOMB2016-09-13
00382830002523NatusXLTEKOMB2016-09-13
00382830002547NatusXLTEKOMB2016-09-13
00382830002554NatusXLTEKOMB2016-09-13
00382830002677NatusXLTEKOMB2016-09-13
00382830002745NatusXLTEKOMB2016-09-13
00382830002820NatusXLTEKOMB2016-09-13
00382830009072NatusXLTEKOMB2016-09-13
00382830016643NatusXLTEKOMB2016-09-13