Duns Number:141668116
Device Description: Standard Adult Cannula with 4ft Supply Tube
Catalog Number
RES1104
Brand Name
Standard Adult Cannula with 4ft Supply Tube
Version/Model Number
RES1104
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
-
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
6e00fe80-bd08-447b-a05e-cbe62d4e70b7
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
May 29, 2018
Package DI Number
10848530060845
Quantity per Package
50
Contains DI Package
00848530060848
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 |