Duns Number:314101143
Device Description: SO2 Optical Module (Type P) for use with M1011A SO2 Module as for intravascular catheters SO2 Optical Module (Type P) for use with M1011A SO2 Module as for intravascular catheters such as scvO2 and svO2. See Instructions for Use for compatible catheters, catheters are not available from Philips.
Catalog Number
989803151591
Brand Name
Philips SO2 Optical Module
Version/Model Number
SO2 Optical 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)
-
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
bc7aea4f-c0a2-47ea-8f2e-680a2238ef7a
Public Version Date
July 11, 2022
Public Version Number
4
DI Record Publish Date
December 18, 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 |