Duns Number:002348191
Device Description: Multi-Lumen Pressure Injectable PICC Set with Blue FlexTip(R) Catheter and 80 cm Platinum Multi-Lumen Pressure Injectable PICC Set with Blue FlexTip(R) Catheter and 80 cm Platinum Tipped, Stainless Steel Marked Wire
Catalog Number
PR-35563-HPSM
Brand Name
ARROW
Version/Model Number
IPN033480
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
K080604,K080604
Product Code
LJS
Product Code Name
Catheter,intravascular,therapeutic,long-term greater than 30 days
Public Device Record Key
a2c68133-c3d7-4979-b214-f6cd623e2519
Public Version Date
July 02, 2021
Public Version Number
11
DI Record Publish Date
October 16, 2015
Package DI Number
30801902095672
Quantity per Package
5
Contains DI Package
00801902095671
Package Discontinue Date
-
Package Status
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 |