Duns Number:022721133
Device Description: Nasal Cannula (Adult) High Flow with 25’ (7.6 m) supply tube, for flows up to 15 LPM
Catalog Number
M014158-0
Brand Name
N/A
Version/Model Number
M014158-0
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
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
12e84e4a-301b-48cb-8c42-e1c822c8f88c
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
December 16, 2016
Package DI Number
10607411401272
Quantity per Package
10
Contains DI Package
00607411401275
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 |