Duns Number:002348191
Device Description: Pressure Injectable Three-Lumen Hemodialysis Catheterization for High Volume Infusions
Catalog Number
AK-15123-PCDC
Brand Name
ARROW
Version/Model Number
IPN919358
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
-
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
420e5f3c-dcc1-4741-a803-f45ac2a8749f
Public Version Date
January 13, 2022
Public Version Number
1
DI Record Publish Date
January 05, 2022
Package DI Number
20801902186496
Quantity per Package
5
Contains DI Package
10801902186499
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 |