Duns Number:206449154
Device Description: The Single-use Adult Nasal Cannula with Tubing is used to deliver supplemental oxygen to a The Single-use Adult Nasal Cannula with Tubing is used to deliver supplemental oxygen to an adult patient in need of respiratory help. This device consists of a nose prong, a thin tube, a quick disconnector and oxygen tubing.
Catalog Number
02RT1012-CS
Brand Name
O-Two
Version/Model Number
02RT1012
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"
-
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
2731d45c-ed37-4ec9-9390-852f72779161
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
October 31, 2019
Package DI Number
17540195071329
Quantity per Package
50
Contains DI Package
07540195071322
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 | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |
| U | Unclassified | 3 |