Duns Number:314101143
Device Description: IntelliVue MP5SC Configured Patient Monitor with 8.4" TFT SVGA display. Primary input devi IntelliVue MP5SC Configured Patient Monitor with 8.4" TFT SVGA display. Primary input device is Touch. 3 waves, Guardian Early Warning Scoring, Multi-patient, Spot-check, Interface (USB, LAN, Battery operation, Nurse call, Video out, Wireless ready), One Lithium Ion battery standard.
Catalog Number
865322
Brand Name
PHILIPS IntelliVue MP5SC Spotcheck Monitor
Version/Model Number
IntelliVue Patient Monitor MP5SC
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
ec8f2083-ef93-4315-906e-f7e57755d241
Public Version Date
August 16, 2022
Public Version Number
9
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 |