Duns Number:790605856
Device Description: IntelliVue MX40 Patient Worn Monitor operating on Hospital-supplied 802.11 a/b/g/n WLAN fo IntelliVue MX40 Patient Worn Monitor operating on Hospital-supplied 802.11 a/b/g/n WLAN for communication to the Philips IntelliVue Information Center iX
Catalog Number
865352
Brand Name
IntelliVue MX40 WLAN
Version/Model Number
MX40 - WLAN
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)
-
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
d3afb4e4-4622-4509-9ed2-38aa9ac46123
Public Version Date
June 14, 2022
Public Version Number
10
DI Record Publish Date
September 22, 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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 323 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 1 |