Duns Number:058614483
Device Description: Acute Dual Lumen Catheter Tray,High Flow Pre-Curved with IC* Safety Components
Catalog Number
-
Brand Name
MAHURKAR
Version/Model Number
8888135140
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"
-
For Single-Use
-
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
K030209,K030209
Product Code
MPB
Product Code Name
CATHETER, HEMODIALYSIS, NON-IMPLANTED
Public Device Record Key
fcd7baca-8226-4719-97dc-0778ec977908
Public Version Date
October 24, 2022
Public Version Number
6
DI Record Publish Date
May 28, 2017
Package DI Number
10884521519534
Quantity per Package
15
Contains DI Package
20884521058382
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 | 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 |