Duns Number:002348191
Device Description: Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Cathete Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter
Catalog Number
ASK-04001-DU9
Brand Name
ARROW
Version/Model Number
IPN036054
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K103255,K103255
Product Code
OBJ
Product Code Name
Catheter, ultrasound, intravascular
Public Device Record Key
67b11a70-9ed2-4b93-ba1f-34c6da7ad009
Public Version Date
March 21, 2019
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
30801902111464
Quantity per Package
3
Contains DI Package
00801902111463
Package Discontinue Date
May 09, 2018
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 |