Duns Number:603130928
Device Description: The Ox-Imager CS™ is intended for use by healthcare professionals as a noninvasive tissue The Ox-Imager CS™ is intended for use by healthcare professionals as a noninvasive tissue oxygenation measurement system that maps value of: oxygensaturation, oxy-hemoglobin, and deoxy-hemoglobin into 2D/3D visual presentations.
Catalog Number
-
Brand Name
Ox-Imager
Version/Model Number
CS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 15, 2019
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
MUD
Product Code Name
Oximeter, Tissue Saturation
Public Device Record Key
be74ea2a-9de4-42d2-8376-a85a94764286
Public Version Date
July 01, 2020
Public Version Number
5
DI Record Publish Date
January 19, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |