Duns Number:314101143
Device Description: Intravascular Oxygen Saturation Module for use with IntelliVue Patient Monitors. The Modul Intravascular Oxygen Saturation Module for use with IntelliVue Patient Monitors. The Module allows continuous measurement of mixed venous oxygen saturation (SvO2) and central venous oxygen saturation (ScvO2).
Catalog Number
865124
Brand Name
PHILIPS IntelliVue Intravascular Oxygen Saturation Module
Version/Model Number
Intravascular Oxygen Saturation 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
DQA
Product Code Name
Oximeter
Public Device Record Key
db9499fa-6830-4e17-9506-376178ec487f
Public Version Date
August 15, 2022
Public Version Number
7
DI Record Publish Date
October 12, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 209 |