FDA.reportPublic FDA data

REMI

Primary DI
00860005388134
Brand
REMI
Company
Epitel, Inc.
Model
E001-20047
Device description
REMI Wireless EEG Sensor
Published
2022-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
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
00860005388134PackageGS11In Commercial Distribution
00860005388141PackageGS14Not in Commercial Distribution
10860005388100PackageGS14In Commercial Distribution
00860005388103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005388134008600053881348600053881340860005388134
00860005388141008600053881418600053881410860005388141
1086000538810010860005388100
00860005388103008600053881038600053881030860005388103

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
Depth0.25Inch
Length1Inch
Width1Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
808401157
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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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