Duns Number:058614483
Device Description: Acute Dual Lumen Catheter Tray,Straight Extensions with IC* Safety Components,12 Fr/Ch (4. Acute Dual Lumen Catheter Tray,Straight Extensions with IC* Safety Components,12 Fr/Ch (4.0 mm) x 20 cm
Catalog Number
8888221420
Brand Name
MAHURKAR Elite
Version/Model Number
8888221420
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
MPB
Product Code Name
CATHETER, HEMODIALYSIS, NON-IMPLANTED
Public Device Record Key
cb9c5760-e117-4d38-abd4-8e3abbf44e69
Public Version Date
February 05, 2021
Public Version Number
7
DI Record Publish Date
April 04, 2016
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 |