Duns Number:002348191
Device Description: Adult Advanced Comfort Fit® Hi-Flo (1-15LPM) Nasal Cannula with 14 ft. (4.2m) Green Star L Adult Advanced Comfort Fit® Hi-Flo (1-15LPM) Nasal Cannula with 14 ft. (4.2m) Green Star Lumen® Tubing, ClearConnect™
Catalog Number
1867CC
Brand Name
HUDSON RCI
Version/Model Number
IPN049698
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
cac4956d-d820-4dac-af91-43b81c1b54d7
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
September 15, 2018
Package DI Number
34026704642916
Quantity per Package
25
Contains DI Package
14026704642912
Package Discontinue Date
-
Package Status
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 |