TidalPort Vascular Access Port - Standard Titanium TidalPort Vascular Access Port - NORFOLK MEDICAL

Duns Number:013861471

Device Description: Standard Titanium TidalPort Vascular Access Port with 9F detached Polyurethane Catheter

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

SP31422

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

Product Characteristics

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 Details

Product Code

LJT

Product Code Name

PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Device Record Status

Public Device Record Key

dd71896c-339c-49ef-a27f-5d9e3b30737d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 01, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NORFOLK MEDICAL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 239