Duns Number:002348191
Device Description: Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions
Catalog Number
AK-12142-F
Brand Name
ARROW
Version/Model Number
IPN036975
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
MPB
Product Code Name
CATHETER, HEMODIALYSIS, NON-IMPLANTED
Public Device Record Key
f3d24363-a62a-4138-9556-0ce0ef89e9a1
Public Version Date
June 17, 2021
Public Version Number
6
DI Record Publish Date
December 14, 2018
Package DI Number
70801902123281
Quantity per Package
5
Contains DI Package
80801902123288
Package Discontinue Date
June 16, 2021
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 |