Duns Number:058614483
Device Description: Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components
Catalog Number
-
Brand Name
MAHURKAR
Version/Model Number
8888102003HP
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
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
-
Product Code
NIE
Product Code Name
CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
Public Device Record Key
d5feeb4b-283d-4730-9083-096647432ed2
Public Version Date
October 07, 2022
Public Version Number
7
DI Record Publish Date
March 12, 2018
Package DI Number
20884521127996
Quantity per Package
5
Contains DI Package
10884521127999
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| 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 |