Duns Number:002348191
Device Description: Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions
Catalog Number
AK-16123-PCDC
Brand Name
ARROW
Version/Model Number
IPN036184
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NIE
Product Code Name
CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
Public Device Record Key
e5eb784e-9624-4427-bda5-2569a2c0abc2
Public Version Date
December 08, 2020
Public Version Number
3
DI Record Publish Date
December 11, 2018
Package DI Number
40801902111744
Quantity per Package
5
Contains DI Package
30801902111747
Package Discontinue Date
December 01, 2020
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 |