Duns Number:690625850
Device Description: K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a K-Shield Advantage Port Access Infusion Set is an intravascular administration set with a noncoring Huber needle that is used to access an implanted medication port for solution infusion.The Port Access Infusion Set is designed with an integral safety device intended to protect against accidental needlestick injuries when removing the device from the implanted port.
Catalog Number
PA04001
Brand Name
K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET
Version/Model Number
PA04001
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
0d7e5c85-0b89-46d4-9053-c40587fe659f
Public Version Date
April 15, 2022
Public Version Number
4
DI Record Publish Date
August 20, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 211 |