Duns Number:058614483
Device Description: GE CARESCAPE (TM) rSO2 - INVOS Parameter;For use with GE Patient Monitors
Catalog Number
-
Brand Name
INVOS
Version/Model Number
PMC71V-GE
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
K182868
Product Code
MUD
Product Code Name
Oximeter, Tissue Saturation
Public Device Record Key
c0da2f6f-fa9c-4f07-b337-f98d45cfd8f5
Public Version Date
August 18, 2022
Public Version Number
6
DI Record Publish Date
January 28, 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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |