Duns Number:002348191
Device Description: Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions
Catalog Number
AK-15123-PCDC
Brand Name
ARROW
Version/Model Number
IPN036181
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
788a19fd-ea99-454e-8876-9adf12e77218
Public Version Date
March 13, 2020
Public Version Number
3
DI Record Publish Date
February 02, 2018
Package DI Number
40801902111713
Quantity per Package
5
Contains DI Package
30801902111716
Package Discontinue Date
March 11, 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 |