Duns Number:020275145
Device Description: Nasal Cannula, Non-Flare, Non-Crush Resistant
Catalog Number
125000
Brand Name
Nasal Cannula, Non-Flare, Non-Crush Resistant
Version/Model Number
Nasal Cannula - 125000
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
a3c7f93a-4200-45bf-a6f5-d01e70487496
Public Version Date
December 25, 2019
Public Version Number
1
DI Record Publish Date
December 17, 2019
Package DI Number
00817081023244
Quantity per Package
50
Contains DI Package
00817081023237
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 | 222 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |