Duns Number:330943838
Device Description: MOX9, Oxygen sensor
Catalog Number
-
Brand Name
MOX9
Version/Model Number
AAD29-210
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCL
Product Code Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Public Device Record Key
c0318568-5c25-4c0f-8e6d-3b79e8afd556
Public Version Date
March 05, 2020
Public Version Number
2
DI Record Publish Date
April 09, 2019
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 | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 175 |