Duns Number:058614483
Device Description: Acute Triple Lumen Catheter,Curved Extensions with 3 Sealing Caps,12.5 Fr/Ch (4.2 mm) x 13 Acute Triple Lumen Catheter,Curved Extensions with 3 Sealing Caps,12.5 Fr/Ch (4.2 mm) x 13 cm
Catalog Number
8888233113
Brand Name
MAHURKAR Elite
Version/Model Number
8888233113
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
K120674,K120674
Product Code
NIE
Product Code Name
CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
Public Device Record Key
bed94f31-cf07-4d53-a4a2-c9f6e502d4b9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 2015
Package DI Number
20884521127606
Quantity per Package
5
Contains DI Package
10884521127609
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 |