Identity
- Trade Name
- Vios Monitoring System Mobile Application FDA UDI
- Generic Name
- Cardiac arrhythmia monitoring system FDA UDI
- Device Name
- The Vios Monitoring System (VMS) Mobile Application is indicated for use by healthcare professionals for centralized monitoring of patient data within a healthcare facility. The Vios Mobile Application receives and displays patient physiological and waveform data and alarms generated by Vios’ proprietary patient vitals monitoring software. The Vios Mobile Application is intended for clinical professionals who are expected to have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients. FDA UDI
- Model / Reference
- VMM2050 Mobile Application FDA UDI
- Description
- The Vios Monitoring System (VMS) Mobile Application is indicated for use by healthcare professionals for centralized monitoring of patient data within a healthcare facility. The Vios Mobile Application receives and displays patient physiological and waveform data and alarms generated by Vios’ proprietary patient vitals monitoring software. The Vios Mobile Application is intended for clinical professionals who are expected to have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients. FDA UDI
Identifiers
- Catalog Number
- VMM2050 FDA UDI
- Primary DI / UDI-DI
- B595VMM2050 FDA UDI
- FDA Product Code
- DXJ FDA UDIOUG FDA UDIQYW FDA UDIDXN FDA UDI
- GMDN Term
- Cardiac arrhythmia monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2450 FDA UDI880.6310 FDA UDI870.1025 FDA UDI870.1130 FDA UDI
- Commercial Distribution
- 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiac arrhythmia monitoring systemClinical management support software
Vios Monitoring System Mobile Application by Murata Vios, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K173107 also covers:
K232354 also covers:
- Vios Monitoring System Bedside Monitor — Murata Vios, Inc.
- Vios Monitoring System Central Server — Murata Vios, Inc.
- Vios Monitoring System Central Station Monitor — Murata Vios, Inc.
- Vios Monitoring System Chest Sensor — Murata Vios, Inc.
- Vios Monitoring System Pulse Oximetry Sensor — Murata Vios, Inc.
- Vios Montioring System Adapter — Murata Vios, Inc.
K241728 also covers:
- Vios Monitoring System Bedside Monitor — Murata Vios, Inc.
- Vios Monitoring System Central Server — Murata Vios, Inc.
- Vios Monitoring System Central Station Monitor — Murata Vios, Inc.
- Vios Monitoring System Chest Sensor — Murata Vios, Inc.
- Vios Monitoring System Pulse Oximetry Sensor — Murata Vios, Inc.
- Vios Montioring System Adapter — Murata Vios, Inc.
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
- Murata Vios, Inc.
Sources (1)
- FDA UDI 08467e2e-95ec-44d9-a98a-55811f6f60e0 36 fields · synced May 31, 2026