Duns Number:002348191
Device Description: PICC Two-Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip(R) Catheter
Catalog Number
PS-01652
Brand Name
ARROW
Version/Model Number
IPN033558
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
K042126,K042126
Product Code
LJS
Product Code Name
Catheter,intravascular,therapeutic,long-term greater than 30 days
Public Device Record Key
08f4ef5f-999c-45e0-8286-a6e1c7000012
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
October 16, 2015
Package DI Number
30801902095825
Quantity per Package
10
Contains DI Package
00801902095824
Package Discontinue Date
December 14, 2017
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 |