Duns Number:013861471
Device Description: Standard Titanium TidalPort Vascular Access Port with 9F detached Silicone Catheter and Va Standard Titanium TidalPort Vascular Access Port with 9F detached Silicone Catheter and Valved Introducer Kit
Catalog Number
SP31412KV
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
f0966c66-05e9-4d4a-8216-5ec1fdee5f4c
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 |