Duns Number:790605856
Device Description: The Efficia CMS200 Central Monitoring System is a "Software with IT Equipment" solution to The Efficia CMS200 Central Monitoring System is a "Software with IT Equipment" solution to provide central viewing of physiologic waves, parameters, and trends from other LAN networked Efficia CM monitors , G series and SureSigns VM4/6/8 monitors (requires sw rev. A.03.93 or later) for up to 64 patients at the same time. It provides for the retrospective review of alarm conditions, physiologic waves and parameters from multiple patients (Up to 240 hours of tabular and graphic trends, ECG waveform, alarm events and full disclosure waveforms). It is built on one Philips supplied HP PC with customized embedded Windows 10 OS, supporting 23" 16:9 high resolution HP displays, 24-port network switch(switch is for selected market), one set of mouse and keyboard(keyboard is for selected market) and one USB licensing dongle. It also can be used with a laserjet printer for printing out reports. The printer can either be Philips supplied or locally sourced. It also has the capability to export HL7 data to EMR/HIS via a second network card. A UPS is not included and recommended to be source locally.
Catalog Number
863352
Brand Name
Efficia CMS200
Version/Model Number
CMS200
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MHX
Product Code Name
MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Public Device Record Key
678d9f59-e10c-4443-b825-cb7f81da5397
Public Version Date
February 21, 2022
Public Version Number
7
DI Record Publish Date
October 03, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 323 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 1 |