Catalog Number

221202

Brand Name

Montgomery® Tracheostomy Speaking Valve

Version/Model Number

221202

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

-

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

K955516,K955516

Product Code

JOH

Product Code Name

Tube Tracheostomy And Tube Cuff

Public Device Record Key

8a0343f1-9d76-48bc-8a8c-783a5e021078

Public Version Date

October 07, 2022

Public Version Number

1

DI Record Publish Date

September 29, 2022

Package DI Number

34063107100018

Quantity per Package

1

Contains DI Package

14063107100014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton