Duns Number:002348191
Device Description: Pressure Injectable Arrowg+ard Blue Advance(R) One-Lumen PICC pre-loaded with Arrow(R) VPS Pressure Injectable Arrowg+ard Blue Advance(R) One-Lumen PICC pre-loaded with Arrow(R) VPS Precision(TM) Stylet
Catalog Number
DLX-45541-VPSB
Brand Name
ARROW
Version/Model Number
IPN924156
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K122545,K122545
Product Code
LJS
Product Code Name
Catheter, intravascular, therapeutic, long-term greater than 30 days
Public Device Record Key
ac0cd5fd-9531-435a-a7a3-a2452f0516d8
Public Version Date
October 28, 2022
Public Version Number
1
DI Record Publish Date
October 20, 2022
Package DI Number
20801902208600
Quantity per Package
3
Contains DI Package
10801902208603
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |