Duns Number:079506014
Device Description: 8F PLASTIC ELLIPTIPORT MID-SIZED CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER
Catalog Number
-
Brand Name
N/A
Version/Model Number
JT150806101
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
f67dc71e-69e2-4577-9cdc-766479f2374d
Public Version Date
November 29, 2019
Public Version Number
1
DI Record Publish Date
November 21, 2019
Package DI Number
50810988021615
Quantity per Package
5
Contains DI Package
00810988021610
Package Discontinue Date
-
Package Status
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 |