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 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
c719dbf7-0d46-41ee-a18d-38f7cc9166fe
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
October 16, 2015
Package DI Number
30801902012938
Quantity per Package
5
Contains DI Package
00801902012937
Package Discontinue Date
November 10, 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 |