Identity
- Trade Name
- Vios Monitoring System Central Station Monitor FDA UDI
- Generic Name
- Centralized patient monitor FDA UDI
- Device Name
- The Vios Monitoring System (VMS) Central Station Monitor (CSM) Software (SW) is indicated for use by healthcare professionals for centralized monitoring of patient data within a healthcare facility. The Vios CSM SW receives, stores, manages, and displays patient physiological and waveform data, and alarms generated by Vios proprietary patient vitals monitoring software. The Vios CSM SW 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
- CSM2050 Software FDA UDI
- Description
- The Vios Monitoring System (VMS) Central Station Monitor (CSM) Software (SW) is indicated for use by healthcare professionals for centralized monitoring of patient data within a healthcare facility. The Vios CSM SW receives, stores, manages, and displays patient physiological and waveform data, and alarms generated by Vios proprietary patient vitals monitoring software. The Vios CSM SW 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
- CSM2050 FDA UDI
- Primary DI / UDI-DI
- B595CSM20500 FDA UDI
- FDA Product Code
- OUG FDA UDIDXJ FDA UDIQYW FDA UDIDXN FDA UDI
- GMDN Term
- Centralized patient monitor FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6310 FDA UDI870.2450 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: Pulse oximeterCentralized patient monitorMultiple vital physiological parameter monitoring system, clinicalCardiac arrhythmia monitoring system
Vios Monitoring System Central Station Monitor by Murata Vios, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Clinical management support software.
- DentalMonitoring - Smile Doctors — Dental Monitoring · Class II
- SIR-Spheres® Microspheres Activity Calculator (SMAC) — SIRTEX MEDICAL PTY LTD · Class II
- AWARE — Ambient Clinical Analytics · Class II
- BioDashboard — BIOINTELLISENSE, INC. · Class II
- Vinehealth Cancer Companion — VINEHEALTH DIGITAL LIMITED · Class I
- Glooko Mobile Insulin Dosing (MIDS) on Glooko WebDashboard — Glooko, Inc. · Class II
- Magstim Analytics — The Magstim Company , Ltd. · Class I
- Insulin Insights™ — MELLITUS HEALTH, INC. · Class II
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 Chest Sensor — Murata Vios, Inc.
- Vios Monitoring System Mobile Application — 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 Chest Sensor — Murata Vios, Inc.
- Vios Monitoring System Mobile Application — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Murata Vios, Inc.
Sources (1)
- FDA UDI d78b8bc2-2c4b-4692-a36f-56ad2da2460a 36 fields · synced May 30, 2026