AccessGUDID - DEVICE: Efficia CMS200 (00884838058309)

GUDID

Device Identifier (DI) Information

Brand Name: Efficia CMS200
Version or Model: CMS200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 863352
Company Name: Philips Medical Systems Hsg

Primary DI Number: 00884838058309
Issuing Agency: GS1
Commercial Distribution End Date: October 03, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 790605856 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38470	Centralized patient monitor	A mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 678d9f59-e10c-4443-b825-cb7f81da5397
Public Version Date: May 20, 2024
Public Version Number: 8
DI Record Publish Date: October 03, 2016