Duns Number:008124539
Device Description: Resp-O2 Nasal Oxygen Cannula, Super Soft Touch, Cushion Tip 14' (4.3m) Crush Resistant Tub Resp-O2 Nasal Oxygen Cannula, Super Soft Touch, Cushion Tip 14' (4.3m) Crush Resistant Tubing, Adult, Standard Connector
Catalog Number
-
Brand Name
Resp-O2 Nasal Oxygen Cannula
Version/Model Number
33145
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
f1f4a648-64bf-42f7-ae60-43129eb20f99
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
April 22, 2021
Package DI Number
00840117316232
Quantity per Package
50
Contains DI Package
00840117316317
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |