Remi

FDA UDI

Class II (US FDA UDI)

by Epitel, Inc.

Identity

Trade Name: REMI FDA UDI
Generic Name: Electroencephalographic monitoring system FDA UDI
Device Name: REMI Ambulatory Patient Starter Kit FDA UDI
Model / Reference: 20110 FDA UDI
Description: REMI Ambulatory Patient Starter Kit FDA UDI

Identifiers

Catalog Number: 20110 FDA UDI
Primary DI / UDI-DI: 00860011072454 FDA UDI
FDA Product Code: OMC FDA UDI
GXY FDA UDI
GMDN Term: Electroencephalographic monitoring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1400 FDA UDI
882.1320 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 1 Inch FDA UDI
Width — 1 Inch FDA UDI
Depth — 0.25 Inch FDA UDI

Category: Electroencephalographic monitoring system Skin cleaning wipe

Remi by Epitel, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Epitel, Inc.

Sources (1)

FDA UDI 5d8516cf-2ea9-4742-aac9-b5afa6fbbd70 37 fields · synced Jun 8, 2026