Duns Number:002348191
Device Description: ADULT Nasal Cannula with 50 Ft. (15 m) STAR LUMEN® Tubing
Catalog Number
1814
Brand Name
HUDSON RCI
Version/Model Number
IPN042811
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
8df8f93b-68a9-4080-89a8-c55eeea2bb79
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
January 23, 2020
Package DI Number
24026704595680
Quantity per Package
25
Contains DI Package
04026704595686
Package Discontinue Date
September 30, 2019
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |