Identity
- Trade Name
- REMI FDA UDI
- Generic Name
- Electroencephalographic monitoring system FDA UDI
- Device Name
- REMI Server FDA UDI
- Model / Reference
- ab3.x.x FDA UDI
- Description
- REMI Server FDA UDI
Identifiers
- Catalog Number
- 20039 FDA UDI
- Primary DI / UDI-DI
- 00860011072461 FDA UDI
- FDA Product Code
- OMC FDA UDI
- GMDN Term
- Electroencephalographic monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Remi by Epitel, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Epitel, Inc.
Sources (1)
- FDA UDI 0b3e2300-c624-4afd-a54a-0cc3466833d1 36 fields · synced May 31, 2026