Duns Number:002348191
Device Description: You-Bend(TM) Two-Lumen Hemodialysis Catheterization Set with Blue FlexTip(R) ARROWg+ard Bl You-Bend(TM) Two-Lumen Hemodialysis Catheterization Set with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter for High Volume Infusions
Catalog Number
CU-23122-F
Brand Name
ARROW
Version/Model Number
IPN030212
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
-
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
21e2d857-ef8c-41fd-8535-b4a1216b2855
Public Version Date
October 21, 2022
Public Version Number
6
DI Record Publish Date
August 31, 2020
Package DI Number
20801902096726
Quantity per Package
5
Contains DI Package
40801902096720
Package Discontinue Date
October 20, 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 |