Duns Number:058614483
Device Description: Acute Triple Lumen Catheter,Curved Extensions,12 Fr/Ch (4.0 mm) x 24 cm
Catalog Number
8888345538
Brand Name
MAHURKAR
Version/Model Number
8888345538
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
-
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
93381695-62b3-486b-ae72-b4a252e0a03c
Public Version Date
March 18, 2022
Public Version Number
4
DI Record Publish Date
April 04, 2016
Package DI Number
20884521056548
Quantity per Package
5
Contains DI Package
10884521056541
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CT
| 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 |