Duns Number:002348191
Device Description: Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R) Catheter for High Volume I Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R) Catheter for High Volume Infusions
Catalog Number
AK-15122-F
Brand Name
ARROW
Version/Model Number
IPN033927
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
Yes
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
f71fbf62-7321-4e09-89a7-0c951e903b6d
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
August 02, 2017
Package DI Number
10801902005790
Quantity per Package
5
Contains DI Package
20801902005797
Package Discontinue Date
November 09, 2017
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 |