Duns Number:002348191
Device Description: Pressure Injectable Three-Lumen Hemodialysis Catheterization for High Volume Infusions
Catalog Number
CDC-12123-XP1A
Brand Name
ARROW
Version/Model Number
IPN036188
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
K993933,K993933
Product Code
NIE
Product Code Name
CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
Public Device Record Key
3e7888be-619d-4a22-ab96-2e29b040896d
Public Version Date
April 01, 2022
Public Version Number
6
DI Record Publish Date
May 03, 2017
Package DI Number
40801902111782
Quantity per Package
5
Contains DI Package
30801902111785
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 |