Duns Number:141668116
Device Description: Standard Adult Cannula with 15ft Supply Tube
Catalog Number
RES1115
Brand Name
Standard Adult Cannula with 15ft Supply Tube
Version/Model Number
RES1115
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
-
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
2047103f-8fe5-45ad-a52a-b44ac8ef855e
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
May 29, 2018
Package DI Number
10848530060883
Quantity per Package
50
Contains DI Package
00848530060886
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 |