Duns Number:022721133
Device Description: Nasal Cannula (Adult) with 4' (1.2 m) supply tube
Catalog Number
M037367-0
Brand Name
N/A
Version/Model Number
M037367-0
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
d586e072-d0d8-4539-9830-58a8c7aaba07
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
December 16, 2016
Package DI Number
10607411000055
Quantity per Package
50
Contains DI Package
00607411000058
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 |