Duns Number:058614483
Device Description: Acute Dual Lumen Catheter Tray High Flow Straight Extensions with IC* Components
Catalog Number
8888135141
Brand Name
MAHURKAR
Version/Model Number
8888135141
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
K030209,K030209
Product Code
MPB
Product Code Name
Catheter, Hemodialysis, Non-Implanted
Public Device Record Key
9dbe0107-bea7-4d2f-99ce-d0c457583558
Public Version Date
October 24, 2022
Public Version Number
6
DI Record Publish Date
September 25, 2016
Package DI Number
10884521519541
Quantity per Package
15
Contains DI Package
20884521058399
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 |