Duns Number:002348191
Device Description: Arrowg+ard Blue Advance(TM) PICC pre-loaded with ARROW(R) TipTracker(TM) Stylet
Catalog Number
CDC-45563-TTS
Brand Name
ARROW
Version/Model Number
IPN037878
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
K160925,K160925
Product Code
LJS
Product Code Name
Catheter,intravascular,therapeutic,long-term greater than 30 days
Public Device Record Key
998b50a3-881f-4f57-99bd-48ae8fd233c5
Public Version Date
May 16, 2022
Public Version Number
11
DI Record Publish Date
November 15, 2017
Package DI Number
40801902132886
Quantity per Package
3
Contains DI Package
30801902132889
Package Discontinue Date
-
Package Status
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 |