Duns Number:314101143
Device Description: The IntelliVue FMX-4 Flexible Module Rack provides 4 module slots for use with individual The IntelliVue FMX-4 Flexible Module Rack provides 4 module slots for use with individual measurement modules and the recorder. The optional E20 Multi Measurement Module mount provides a mounting plate with an SRL connector for attaching a multi-measurement module. The FMX-4 is only compatible with IntelliVue MX750 and MX850 patient monitors.
Catalog Number
866468
Brand Name
Philips IntelliVue Patient Monitoring
Version/Model Number
Flexible Module Server FMX-4
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
8a17a85a-ab9e-4b83-ac89-c2264ade1e78
Public Version Date
September 30, 2022
Public Version Number
4
DI Record Publish Date
November 29, 2021
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 |