Duns Number:314101143
Device Description: IntelliVue TcG10 Gas Modul for external transcutaneous O2 and CO2 measurement
Catalog Number
865298
Brand Name
PHILIPS IntelliVue TcG10
Version/Model Number
IntelliVue TcG10
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
LKD
Product Code Name
MONITOR, CARBON-DIOXIDE, CUTANEOUS
Public Device Record Key
f581ae5a-2d85-4b0d-9c9b-a6b218c68c0a
Public Version Date
August 15, 2022
Public Version Number
5
DI Record Publish Date
December 15, 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 |