Duns Number:141668116
Device Description: Soft Adult Cannula Only with Female Port
Catalog Number
RES1100FS
Brand Name
Soft Adult Cannula Only with Female Port
Version/Model Number
RES1100FS
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
3e5cc85f-6e5e-4289-830b-305246881a86
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
September 19, 2018
Package DI Number
10848530086975
Quantity per Package
50
Contains DI Package
00848530086978
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 |