Duns Number:002348191
Device Description: ARROW(R) PICC Set
Catalog Number
PR-35541-HPHNL
Brand Name
ARROW
Version/Model Number
IPN033446
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
83ed2b12-fb21-46ac-8aee-89d8c083e4df
Public Version Date
June 21, 2021
Public Version Number
12
DI Record Publish Date
October 16, 2015
Package DI Number
30801902095566
Quantity per Package
5
Contains DI Package
00801902095565
Package Discontinue Date
June 17, 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 |