Duns Number:314101143
Device Description: Masimo O3 Plug-in Module for IntelliVue Patient Monitors to connect the Masimo O3 Measurem Masimo O3 Plug-in Module for IntelliVue Patient Monitors to connect the Masimo O3 Measurement Device (989803203021)
Catalog Number
867184
Brand Name
PHILIPS Masimo O3 Module
Version/Model Number
Masimo O3 Module
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
DSI
Product Code Name
Detector And Alarm, Arrhythmia
Public Device Record Key
fad503e6-1b79-41a8-9d83-3288223a8ab3
Public Version Date
September 15, 2022
Public Version Number
4
DI Record Publish Date
October 14, 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 |