Catalog Number

-

Brand Name

TrachVox

Version/Model Number

313-1000

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"

-

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

K013728,K013728

Product Code

JOH

Product Code Name

Tube Tracheostomy And Tube Cuff

Public Device Record Key

7134b696-cd52-46fe-9cd1-f8f0cb7f98df

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 11, 2016

Package DI Number

10841470101098

Quantity per Package

50

Contains DI Package

00841470101091

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-