Duns Number:314101143
Device Description: IntelliVue MP5 Configured Patient Monitor with 8.4" TFT SVGA display. Primary input device IntelliVue MP5 Configured Patient Monitor with 8.4" TFT SVGA display. Primary input device is Touch.
Catalog Number
865024
Brand Name
PHILIPS IntelliVue MP5
Version/Model Number
IntelliVue MP5
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
7a3ec8ae-61fb-46e6-9a6c-5e64658d6919
Public Version Date
July 20, 2022
Public Version Number
8
DI Record Publish Date
September 28, 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 |