Catalog Number

TFK-08

Brand Name

Tru-Fix Catheter Fixation Kit

Version/Model Number

TFK-08

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

June 30, 2026

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Public Device Record Key

ce42a0ac-bd29-4306-a22f-6fae6ea338cc

Public Version Date

May 13, 2022

Public Version Number

6

DI Record Publish Date

August 31, 2016

Package DI Number

H862TFK082

Quantity per Package

5

Contains DI Package

H862TFK081

Package Discontinue Date

June 30, 2026

Package Status

In Commercial Distribution

Package Type

Shipper