REMI

Basic Information

• Brand Name: REMI
• Primary DI: 00860005388103
• Version / Model: E001-20047
• Company Name: Epitel, Inc.
• Labeler DUNS: 808401157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-16
• Public Version: 1
• Public Version Date: 2022-12-26
• Public Version Status: New
• Public Device Record Key: d35adf76-4d14-4326-8ab4-212186c5cd75

Device Description

REMI Wireless EEG Sensor

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	882.1400	2
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38736	Electroencephalographic monitoring system	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00860005388134	GS1	Single Unit	1	In Commercial Distribution
Primary	00860005388103	GS1
Package	10860005388100	GS1	Carton	4	In Commercial Distribution
Package	00860005388141	GS1	Shipper	4	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K203827	000

Device Sizes

Type	Value	Unit	Text
Length	1	Inch
Width	1	Inch
Depth	0.25	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity