Duns Number:002348191
Device Description: Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Sharps Safety Feat Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Sharps Safety Features
Catalog Number
AK-16123-PCDC
Brand Name
ARROW
Version/Model Number
IPN036183
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
4e44f34c-f893-4c69-8c79-1513dc02e3a7
Public Version Date
October 11, 2019
Public Version Number
2
DI Record Publish Date
December 11, 2018
Package DI Number
30801902111730
Quantity per Package
5
Contains DI Package
40801902111737
Package Discontinue Date
October 07, 2019
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 |