AccessGUDID - DEVICE: IntelliVue MX40 1.4GHz (00884838082236)

GUDID

Device Identifier (DI) Information

Brand Name: IntelliVue MX40 1.4GHz
Version or Model: MX40 1.4 GHz Smart Hopping
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 865350
Company Name: Philips Medical Systems Hsg

Primary DI Number: 00884838082236
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790605856 *Terms of Use

Device Description: IntelliVue MX40 Patient Worn Monitor operating on the IntelliVue 1.4 GHz Smart-hopping Network for communication to the Philips IntelliVue Information Center or Philips IntelliVue Information Center iX.

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 50 Degrees Celsius
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: bd969c24-f280-4c34-87d5-6988a5be049c
Public Version Date: March 13, 2023
Public Version Number: 10
DI Record Publish Date: September 22, 2016