Duns Number:002348191
Device Description: ARROW(R) Pressure Injectable Multi-Lumen PICC Kit
Catalog Number
CDC-05063-HPK1A
Brand Name
ARROW
Version/Model Number
IPN036413
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
206b2d6a-1ec1-4165-adc6-2deceace6e54
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
October 09, 2017
Package DI Number
30801902123412
Quantity per Package
5
Contains DI Package
20801902123415
Package Discontinue Date
April 30, 2018
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 |