Duns Number:790605856
Device Description: CareEvent is a distributed alarming solution. With CareEvent the Philips Alarm distributio CareEvent is a distributed alarming solution. With CareEvent the Philips Alarm distribution solution includes rules and escalation levels to deliver the right alarm to the right caregiver with the right information on a mobile device.
Catalog Number
866435
Brand Name
CareEvent
Version/Model Number
CareEvent
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
MSX
Product Code Name
System, network and communication, physiological monitors
Public Device Record Key
6b1bb35e-7cf5-459f-863b-7ea6beb742bb
Public Version Date
February 16, 2022
Public Version Number
4
DI Record Publish Date
November 25, 2019
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 |