AccessGUDID - DEVICE: IntelliVue Patient Monitor MX700 (00884838029088)

GUDID

Device Identifier (DI) Information

Brand Name: IntelliVue Patient Monitor MX700
Version or Model: IntelliVue Patient Monitor MX700
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 865241
Company Name: Philips Medizin Systeme Böblingen GmbH

Primary DI Number: 00884838029088
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314101143 *Terms of Use

Device Description: The IntelliVue MX700 patient monitor is operated primarily via touchscreen. It has an integrated 15" TFT widescreen touch display. It is compatible with the MMS (M3001A) / X2 (M3002A) Multi-Measurement Modules/ all Multi-measurement module extensions/ IntelliVue MMX (867036)/ IntelliVue X3 (867030), the FMS Module Racks (FMS-4 and FMS-8) and the individual IntelliVue measurement modules.

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?
33586	General-purpose multi-parameter bedside monitor	An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and 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: abc0b172-fff7-42a4-8883-9592e23758b9
Public Version Date: July 27, 2023
Public Version Number: 12
DI Record Publish Date: September 26, 2016