Duns Number:022721133
Device Description: Nasal Cannula (adult) Salter Style with 4’ (1.2 m) supply tube
Catalog Number
SO-2085
Brand Name
N/A
Version/Model Number
SO-2085
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
-
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
a7686b79-1d8c-440b-b098-2636ec8bf65a
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
March 30, 2018
Package DI Number
10607411961042
Quantity per Package
50
Contains DI Package
00607411961045
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 | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |