Duns Number:002348191
Device Description: Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions
Catalog Number
AK-15122-J
Brand Name
ARROW
Version/Model Number
IPN032653
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
K810675,K810675
Product Code
DQX
Product Code Name
Wire, guide, catheter
Public Device Record Key
e7e4e341-4414-4f25-ba65-26604a217542
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
August 30, 2017
Package DI Number
10801902001037
Quantity per Package
5
Contains DI Package
20801902001034
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 |