Duns Number:002348191
Device Description: You-Bend(TM) Two-Lumen Hemodialysis Catheterization Set with Blue Flextip(R) Catheter for You-Bend(TM) Two-Lumen Hemodialysis Catheterization Set with Blue Flextip(R) Catheter for High Volume Infusions
Catalog Number
CV-13122-F
Brand Name
ARROW
Version/Model Number
IPN030872
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K895417,K895417
Product Code
LFJ
Product Code Name
Catheter, subclavian
Public Device Record Key
5be0f075-d4f1-40e3-95b8-d687b6c6b1ac
Public Version Date
March 23, 2022
Public Version Number
11
DI Record Publish Date
October 16, 2015
Package DI Number
30801902029240
Quantity per Package
5
Contains DI Package
00801902029249
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 |