Duns Number:058614483
Device Description: Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC* Safety Component Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC* Safety Components
Catalog Number
8888233420
Brand Name
MAHURKAR Elite
Version/Model Number
8888233420
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
K120674
Product Code
NIE
Product Code Name
Catheter, hemodialysis, triple lumen, non-implanted
Public Device Record Key
720b7fc1-cadf-4d99-b40e-04f9b62e1ed9
Public Version Date
October 15, 2020
Public Version Number
2
DI Record Publish Date
April 18, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |