Duns Number:002348191
Device Description: ARROW(R) PICC Set
Catalog Number
PR-35041-HPHNM
Brand Name
ARROW
Version/Model Number
IPN033412
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
K113277,K113277
Product Code
LJS
Product Code Name
Catheter,intravascular,therapeutic,long-term greater than 30 days
Public Device Record Key
4968c0e4-8150-444c-a871-1a60f06d4cd4
Public Version Date
July 12, 2021
Public Version Number
8
DI Record Publish Date
October 16, 2015
Package DI Number
30801902101052
Quantity per Package
5
Contains DI Package
00801902101051
Package Discontinue Date
July 08, 2021
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 |