Duns Number:022721133
Device Description: Nasal Cannula (Adult) Salter Style ® with 7’ (2. 1 m) supply tube for oxygen flows up to 8 Nasal Cannula (Adult) Salter Style ® with 7’ (2. 1 m) supply tube for oxygen flows up to 8 LPM
Catalog Number
M128348-0
Brand Name
N/A
Version/Model Number
M128348-0
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
ea6384dd-ede1-4c45-9f1e-ab14feda13d6
Public Version Date
March 22, 2022
Public Version Number
4
DI Record Publish Date
December 22, 2016
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 | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |