Identity
- Trade Name
- Remote Monitoring System FDA UDI
- Generic Name
- Electroencephalographic monitoring system FDA UDI
- Device Name
- The Remote Monitoring Station (RMS) software is designed to display CSC and, when available, live video data captured from the Pegasus data acquisition software on a networked computer. FDA UDI
- Model / Reference
- 1.0.0 FDA UDI
- Description
- The Remote Monitoring Station (RMS) software is designed to display CSC and, when available, live video data captured from the Pegasus data acquisition software on a networked computer. FDA UDI
Identifiers
- Catalog Number
- 36-0301-0002 FDA UDI
- Primary DI / UDI-DI
- 00850011306680 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Remote Monitoring System by Neuralynx, 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 |
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Manufacturer
- Manufacturer
- Neuralynx, Inc.
Sources (1)
- FDA UDI 3a636138-89ec-41b3-923f-2e7d654beae5 36 fields · synced May 31, 2026