Catalog Number

350801

Brand Name

Montgomery® Cannula Speaking Valve

Version/Model Number

350801

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Product Code

JOH

Product Code Name

Tube Tracheostomy And Tube Cuff

Public Device Record Key

f3a21816-2299-4579-877f-14d39193bc65

Public Version Date

August 30, 2022

Public Version Number

5

DI Record Publish Date

September 20, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-