Duns Number:013861471
Device Description: Low-Profile Titanium TidalPort Vascular Access Port with 7F preattached Polyurethane Cathe Low-Profile Titanium TidalPort Vascular Access Port with 7F preattached Polyurethane Catheter and Valved Introducer Kit
Catalog Number
SP21321KV
Brand Name
TidalPort Vascular Access Port
Version/Model Number
TidalPort
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
7ab1ee1e-4aab-45b0-9ef1-fe7d69d97219
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 01, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 239 |