FDA.reportPublic FDA data

REMI

Primary DI
00860005388127
Brand
REMI
Company
Epitel, Inc.
Model
R001-20053
Device description
REMI Tablet
Published
2022-12-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
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
00860005388127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005388127008600053881278600053881270860005388127

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic monitoring systemAn electrically-powered device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function, typically in an examination room or intensive care unit (ICU) [bedside]; it may also monitor additional physiological parameters [e.g., electromyogram (EMG), respiration wave forms, blood pressure, haemoglobin oxygen saturation (SpO2)] in relation to EEG. It typically includes a control unit, electrodes, and components (e.g., amplifier, cables, probes). It may include data interpretation and/or telemetry features.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height6Inch
Width10.3Inch

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
808401157
Device count
1
Serial number
true
Manufacturing date on label
true

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
00860005388134REMIE001-200472022-12-16
00860005388189REMI Vigilenz1.x.x201042024-03-11
08600053881032EpilogE0012022-01-01
08600053881650REMIR0012022-01-01
08600053881278EpilogE0012022-01-01

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05999860882060QUEX EDQX WORLD LTDOMC2026-04-27
05999860882077QUEX SQX WORLD LTDOMC2026-04-27
B566847020ZmachineGeneral SleepOMC2026-04-16
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyOMC2026-04-15
B566847001ZmachineGeneral SleepOMC2026-04-09
B566847002ZmachineGeneral SleepOMC2026-04-09
09357225002014Nurochek-Pro HeadsetHEADSAFE MFG PTY LTDOMC2026-03-18
09342451002655Compumedics SomfitCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002662Compumedics SomfitCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002747Compumedics FalconCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002754Compumedics FalconCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002785Compumedics FalconCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002822Compumedics SomfitCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002860Compumedics SomfitCOMPUMEDICS LIMITEDOMC2026-03-12
09342451007063Compumedics Somfit DCOMPUMEDICS LIMITEDOMC2026-03-12
09357225000041Nurochek-ProHEADSAFE MFG PTY LTDOMC2026-01-23
00850063034364Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2025-12-22
09357225000034Nurochek-ProHEADSAFE MFG PTY LTDOMC2025-12-15
09357225001017Nurochek-Pro HeadsetHEADSAFE MFG PTY LTDOMC2025-12-15
09357225002021Nurochek-Pro Application HEADSAFE MFG PTY LTDOMC2025-12-15
09357225002038Nurochek-Pro ServerHEADSAFE MFG PTY LTDOMC2025-12-15
09357225003028Nurochek-Pro Soft Sensor KitHEADSAFE MFG PTY LTDOMC2025-12-15
09357225006029Nurochek-Pro Saline SolutionHEADSAFE MFG PTY LTDOMC2025-12-15
B706H10000COGNISION EEG/EP SystemNeuronetrix Solutions, LLCOMC2025-03-12
00382830045100NatusXLTEKOMC2025-02-26
00382830045117NatusXLTEKOMC2025-02-26
00382830045391NatusXLTEKOMC2025-02-26