FDA.reportPublic FDA data

REMI

Primary DI
00860005388158
Brand
REMI
Company
Epitel, Inc.
Model
2.3
Device description
REMI-Cloud
Published
2022-12-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMCReduced- Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMCReduced- Montage Standard ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005388158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005388158008600053881588600053881580860005388158

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
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
00860005388189REMI Vigilenz1.x.x201042024-03-11
08600053881032EpilogE0012022-01-01
08600053881650REMIR0012022-01-01
08600053881278EpilogE0012022-01-01

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Primary DI, Brand, Company table
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