Duns Number:314101143
Device Description: IntelliVue Dock. Docking solution for X3 and MX100 monitors, providing mounting, AC power, IntelliVue Dock. Docking solution for X3 and MX100 monitors, providing mounting, AC power, LAN, and Flexible Sync Out. To be used with standalone IntelliVue X3 or IntelliVue MX100 monitors. Includes Universal Clamp and Cable Management Hook. Note that IntelliVue Dock cannot be used for connecting IntelliVue X3 to an IntelliVue host monitor.
Catalog Number
867043
Brand Name
PHILIPS IntelliVue Dock
Version/Model Number
IntelliVue Dock
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
5c532203-f1a3-41c3-a7a2-869e19151cc7
Public Version Date
August 15, 2022
Public Version Number
5
DI Record Publish Date
November 26, 2018
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 |