Duns Number:044611812
Device Description: PowerPort ClearVUE Slim with Smooth Septum, 8F ChronoFlex Silk Catheter, Open Suture Holes PowerPort ClearVUE Slim with Smooth Septum, 8F ChronoFlex Silk Catheter, Open Suture Holes, Intermediate Kit (Stealth)
Catalog Number
5678301
Brand Name
PowerPort ClearVUE Slim Implantable Port
Version/Model Number
5678301
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LJT
Product Code Name
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Public Device Record Key
ccae73ed-badd-45fc-8acd-9dc8980d8fe2
Public Version Date
October 23, 2019
Public Version Number
5
DI Record Publish Date
January 06, 2016
Package DI Number
10801741110839
Quantity per Package
5
Contains DI Package
00801741110832
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3348 |
| U | Unclassified | 8 |