Duns Number:044611812
Device Description: PowerPort isp M.R.I. Implantable Port With Attachable 8 F ChronoFlex Silk Open-Ended Sing PowerPort isp M.R.I. Implantable Port With Attachable 8 F ChronoFlex Silk Open-Ended Single-Lumen Venous Catheter
Catalog Number
1808360
Brand Name
PowerPort isp M.R.I. Implantable Port
Version/Model Number
1808360
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
9f793943-d5b3-44d1-b0d8-c1fbbc69761b
Public Version Date
October 23, 2019
Public Version Number
5
DI Record Publish Date
July 13, 2017
Package DI Number
10801741108157
Quantity per Package
5
Contains DI Package
00801741108150
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 |