Duns Number:002348191
Device Description: ARROWg+ard Blue(R) Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions
Catalog Number
AK-25122-F
Brand Name
ARROW
Version/Model Number
IPN036960
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
K993933,K993933
Product Code
MPB
Product Code Name
CATHETER, HEMODIALYSIS, NON-IMPLANTED
Public Device Record Key
cfdb9476-9f62-4c8a-b244-2c8722624625
Public Version Date
October 31, 2022
Public Version Number
5
DI Record Publish Date
December 14, 2018
Package DI Number
30801902139741
Quantity per Package
5
Contains DI Package
40801902139748
Package Discontinue Date
October 27, 2022
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 |