Duns Number:092673953
Device Description: CO2/O2 Oral/Nasal Cannula, 10' CO2/O2 with Reflective Luer and Comfort Soft Plus Tubing
Catalog Number
-
Brand Name
Adult Oral/Nasal Cannula
Version/Model Number
0911
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
Yes
For Single-Use
Yes
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
CAT
Product Code Name
Cannula, Nasal, Oxygen
Public Device Record Key
f9fad055-ab3c-4280-80cc-b5600143b4ee
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
June 30, 2019
Package DI Number
10709078007092
Quantity per Package
25
Contains DI Package
00709078007095
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |