Duns Number:002348191
Device Description: ArrowEVOLUTION(TM) PICC Set featuring Chlorag+ard(TM) Antimicrobial/Antithrombogenic Techn ArrowEVOLUTION(TM) PICC Set featuring Chlorag+ard(TM) Antimicrobial/Antithrombogenic Technology with Pressure Injectable Catheter with Blue FlexTip(R)
Catalog Number
PR-44052-HP
Brand Name
ARROW
Version/Model Number
IPN033492
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
K112896,K112896
Product Code
LJS
Product Code Name
Catheter,intravascular,therapeutic,long-term greater than 30 days
Public Device Record Key
8db8c975-affe-47d4-8c8c-be5996f39d04
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
October 16, 2015
Package DI Number
30801902095689
Quantity per Package
5
Contains DI Package
00801902095688
Package Discontinue Date
February 28, 2019
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 |