Duns Number:206449154
Device Description: The Single-use Adult Nasal Cannula is used to deliver supplemental oxygen to an adult pati The Single-use Adult Nasal Cannula is used to deliver supplemental oxygen to an adult patient in need of respiratory help. This device consists of a nose prong and a thin tube.
Catalog Number
02RT1010-CS
Brand Name
O-Two
Version/Model Number
02RT1010
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
77a0a3e5-7ea2-40ba-9cc8-40ac66ee7378
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
October 31, 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 | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |
| U | Unclassified | 3 |