Duns Number:058614483
Device Description: Acute Dual Lumen Catheter Tray High Flow Straight Extensions with IC Components
Catalog Number
8888135139
Brand Name
MAHURKAR
Version/Model Number
8888135139
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 29, 2020
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
K030209,K030209
Product Code
MPB
Product Code Name
Catheter, Hemodialysis, Non-Implanted
Public Device Record Key
f4baed9f-3e3d-4cc4-897b-e7127f03ffe1
Public Version Date
October 20, 2022
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
10884521519527
Quantity per Package
15
Contains DI Package
20884521058375
Package Discontinue Date
April 29, 2020
Package Status
Not 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 |