AccessGUDID - DEVICE: IntelliVue Patient Monitor MX850 (00884838070790)

GUDID

Device Identifier (DI) Information

Brand Name: IntelliVue Patient Monitor MX850
Version or Model: IntelliVue Patient Monitor MX850
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 866470
Company Name: Philips Medizin Systeme Böblingen GmbH

Primary DI Number: 00884838070790
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314101143 *Terms of Use

Device Description: The IntelliVue MX850 Patient Monitor has an optically-bonded 22 inch (547 mm) LCD (TFT) widescreen display with projected capacitive touch technology. It is compatible with various measurement modules and measurement servers. The monitor provides as standard a 100BaseT LAN port, an RS232 port, four USB ports, a basic nurse call relay, and an analog ECG sync output. MX850 also provides two MSL connectors for connecting up to two FMX-4 module racks (either in parallel or serial). Built-in to the front of the display is a Contactless ID and Communication module using RFID technology. Please refer to technical data sheet for more information.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	Yes
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?
36872	Multiple vital physiological parameter monitoring system, clinical	An assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body.	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
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 57 and 106 KiloPascal
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6927d87b-9863-4512-a95a-d5bdc250ea17
Public Version Date: December 20, 2024
Public Version Number: 8
DI Record Publish Date: November 29, 2021