Duns Number:002348191
Device Description: Pressure Injectable PICC Set with Blue FlexTip(R) Catheter and 130 cm Marked Wire
Catalog Number
CA-05052-HPX
Brand Name
ARROW
Version/Model Number
IPN038138
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
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
K061289,K061289,K061289
Product Code
LJS
Product Code Name
Catheter, intravascular, therapeutic, long-term greater than 30 days
Public Device Record Key
f5ab7805-1a48-4453-8808-32fff85cdba5
Public Version Date
October 06, 2020
Public Version Number
4
DI Record Publish Date
August 05, 2019
Package DI Number
40801902136792
Quantity per Package
5
Contains DI Package
30801902136795
Package Discontinue Date
March 25, 2020
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |