PHILIPS IntelliVue MX500 Patient Monitor - The IntelliVue MX500 patient monitor is operated - Philips Medizin Systeme Böblingen GmbH

Duns Number:314101143

Device Description: The IntelliVue MX500 patient monitor is operated primarily via touch screen. It has an int The IntelliVue MX500 patient monitor is operated primarily via touch screen. It has an integrated 12" TFT widescreen touch display and is compatible with the IntelliVue Multi Measurement Module (M3001A)/ IntelliVue X2 (M3002A) and all Multi-Measurement Module Extensions/IntelliVue MMX (867036)/ IntelliVue X3 (867030). The monitor has 3 module slots built-in, that are compatible with supported IntelliVue single and dual width measurement modules (see Technical Data Sheet for list of supported modules).The IntelliVue MX500 comes with a built-in battery bay as standard (battery not included in base product), built-in comfort handle and integrated power supply in order to make the monitor easily portable.

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More Product Details

Catalog Number

866064

Brand Name

PHILIPS IntelliVue MX500 Patient Monitor

Version/Model Number

IntelliVue Patient Monitor MX500

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MHX

Product Code Name

MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Device Record Status

Public Device Record Key

0bbbed09-eae1-4571-9e6f-93cc9513afc6

Public Version Date

February 24, 2022

Public Version Number

7

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 209