Duns Number:002348191
Device Description: Peripherally Inserted Central Catheter Set with Blue FlexTip(R) Catheter Seldinger Access Peripherally Inserted Central Catheter Set with Blue FlexTip(R) Catheter Seldinger Access Set with 130 cm Palladium Tipped, Marked Wire
Catalog Number
PR-05041-LW
Brand Name
ARROW
Version/Model Number
IPN033351
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
K003006,K003006
Product Code
LJT
Product Code Name
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Public Device Record Key
36cd5db7-a564-4d81-b7e0-3590d928ddda
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
November 23, 2017
Package DI Number
20801902012931
Quantity per Package
5
Contains DI Package
10801902012934
Package Discontinue Date
September 18, 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 |