Duns Number:079506014
Device Description: 8F PLASTIC ELLIPTIPORT MID-SIZED CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER
Catalog Number
-
Brand Name
MEDCOMP GEN III POWER INJECTABLE PORT
Version/Model Number
JT150806101
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 22, 2019
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
3c7410e0-9dd7-4412-be98-ad810ebdf8fa
Public Version Date
December 05, 2019
Public Version Number
6
DI Record Publish Date
February 13, 2018
Package DI Number
50810988021202
Quantity per Package
5
Contains DI Package
00810988021207
Package Discontinue Date
November 22, 2019
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 63 |