Catalog Number

TFK-16

Brand Name

Tru-Fix Catheter Fixation Kit

Version/Model Number

TFK-16

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

903a7ced-514e-4f76-b222-f9f7bd0fb0e1

Public Version Date

May 20, 2022

Public Version Number

1

DI Record Publish Date

May 12, 2022

Package DI Number

10817640020698

Quantity per Package

5

Contains DI Package

00817640020691

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser