Duns Number:314101143
Device Description: The IntelliVue MX800 patient monitor is operated primarily via touch screen. It has an int The IntelliVue MX800 patient monitor is operated primarily via touch screen. It has an integrated 19" TFT widescreen touch display and is compatible with the IntelliVue Multi Measurement Module (M3001A)/ IntelliVue X2 (M3002A)/ all Multi-Measurement Module Extensions/IntelliVue MMX (867036)/ IntelliVue X3 (867030)/ the Flexible Module Server (M8048A) and the individual IntelliVue measurement modules.
Catalog Number
865240
Brand Name
PHILIPS IntelliVue MX800 patient monitor
Version/Model Number
IntelliVue Patient Monitor MX800
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
MHX
Product Code Name
MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Public Device Record Key
e765c8d2-3306-4f89-bcce-f019a1f0f840
Public Version Date
August 12, 2022
Public Version Number
9
DI Record Publish Date
September 26, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |