Duns Number:141668116
Device Description: Sunset Adult Soft Cannula with 4ft Supply Tube - High Flow
Catalog Number
RES1104SHF
Brand Name
Sunset Adult Soft Cannula with 4ft Supply Tube - High Flow
Version/Model Number
RES1104SHF
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)
-
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
fe509dc2-6bea-4e09-b0e0-451f4ea2c69c
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
January 17, 2019
Package DI Number
10848530089693
Quantity per Package
25
Contains DI Package
00848530089696
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 | 160 |
2 | A medical device with a moderate to high risk that requires special controls. | 68 |