Duns Number:002348191
Device Description: Pressure Injectable Multi-Lumen PICC Kit with Blue Flex Tip(R) Catheter
Catalog Number
PR-05563-HPX
Brand Name
ARROW
Version/Model Number
IPN036816
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080604,K080604
Product Code
LJS
Product Code Name
Catheter,intravascular,therapeutic,long-term greater than 30 days
Public Device Record Key
53c173bc-4a76-41d7-983e-f32daa654f0d
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
August 18, 2017
Package DI Number
20801902124177
Quantity per Package
5
Contains DI Package
30801902124174
Package Discontinue Date
April 15, 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 |