FDA.reportPublic FDA data

Tracheostomy tube speech valve

Definition
A device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded.
GUDID devices
99
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07331791008238Freevent Connection strapAtos Medical AB77462022-11-28
07350061231084SPIROFogless International AB7072018-03-31
07350061231107SPIROFogless International AB7082018-03-31
07350061231220SPIROFogless International AB7302018-03-31
10859760005018Passy-MuirPASSY-MUIR, INC.PMV 005 2016-09-16
10859760005025Passy-MuirPASSY-MUIR, INC.PMV 0072016-09-16
10859760005032Passy-MuirPASSY-MUIR, INC.PMV 2020 2016-09-16
10859760005063Passy-MuirPASSY-MUIR, INC.PMV 2000 2016-09-16
10859760005087Passy-MuirPASSY-MUIR, INC.PMA 20002016-09-16
10859760005148Passy-MuirPASSY-MUIR, INC.PMV 20012016-09-16
10884521751354ShileyCovidien LPSSV2018-02-06
10884521751361ShileyCovidien LPSSVO2018-02-06
14063107100007Montgomery® Tracheostomy Speaking ValveBoston Medical Products, Inc.2212012022-09-29
14063107100014Montgomery® Tracheostomy Speaking ValveBoston Medical Products, Inc.2212022022-09-29
14063107100939Montgomery® Cannula Speaking ValveBoston Medical Products, Inc.3504012022-09-29
14063107100984Montgomery® Cannula Speaking ValveBoston Medical Products, Inc.3506012022-09-29
14063107101035Montgomery® Cannula Speaking ValveBoston Medical Products, Inc.3508012022-09-29
14063107101080Montgomery® Cannula Speaking ValveBoston Medical Products, Inc.3510012022-09-29
40884522005365ShileyCovidien LPSSV2015-09-02
40884522005372ShileyCovidien LPSSVO2015-09-02
50884522007724ShileyCovidien LPSSV2015-09-02
04035324012923TRACOE® modularTracoe medical GmbHREF 650-SO2015-10-18
04035324054510TRACOE® modularTracoe medical GmbHREF 650-S2015-10-18
04035324012930TRACOE modularTracoe medical GmbHREF 650-TO2015-10-18
04035324019151TRACOE modularTracoe medical GmbHREF 650-TO-52015-10-18
04035324020140TRACOE modularTracoe medical GmbHREF 650-TO-C2015-10-18
04035324020157TRACOE modularTracoe medical GmbHREF 650-TO-C-52015-10-18
04035324054619TRACOE modularTracoe medical GmbHREF 650-T2015-10-18
07350061230353SPIROFogless International ABXXX2023-09-21
07331791015175Provox Life FreeHands FlexiVoice Set PlusAtos Medical AB82102022-12-07
07331791016530Freevent Connection strapAtos Medical AB77462022-11-28
34063107100001Montgomery® Tracheostomy Speaking ValveBoston Medical Products, Inc.2212012022-09-29
34063107100018Montgomery® Tracheostomy Speaking ValveBoston Medical Products, Inc.2212022022-09-29
34063107100933Montgomery® Cannula Speaking ValveBoston Medical Products, Inc.3504012022-09-29
34063107100988Montgomery® Cannula Speaking ValveBoston Medical Products, Inc.3506012022-09-29
34063107101039Montgomery® Cannula Speaking ValveBoston Medical Products, Inc.3508012022-09-29
34063107101084Montgomery® Cannula Speaking ValveBoston Medical Products, Inc.3510012022-09-29
20884521751351ShileyCovidien LPSSV2018-02-06
20884521751368ShileyCovidien LPSSVO2018-02-06
07331791015021Freevent DualCare Set 15Atos Medical AB77412020-05-29
07331791015038Freevent DualCare Set 22Atos Medical AB77402020-05-29
07331791015045Freevent DualCare Speaking ValveAtos Medical AB77442020-05-29
07331791015052Freevent DualCare Speaking Valve BlueAtos Medical AB77552020-05-29
07331791015083Freevent® HME 15 RegularAtos Medical AB77422020-05-29
07331791015090Freevent® HME 22 RegularAtos Medical AB77472020-05-29
EBES2212011Montgomery® Tracheostomy Speaking ValveBoston Medical Products, Inc.2212012015-09-20
EBES2212021Montgomery® Tracheostomy Speaking ValveBoston Medical Products, Inc.2212022015-09-20
EBES2214011Montgomery® VENTRACH™ Speaking ValveBoston Medical Products, Inc.2214012015-09-20
EBES3504011Montgomery® Cannula Speaking ValveBoston Medical Products, Inc.3504012015-09-20
EBES3504021Montgomery® Cannula Speaking ValveBoston Medical Products, Inc.3504022015-09-20
EBES3506011Montgomery® Cannula Speaking ValveBoston Medical Products, Inc.3506012015-09-20
EBES3506021Montgomery® Cannula Speaking ValveBoston Medical Products, Inc.3506022015-09-20
EBES3508011Montgomery® Cannula Speaking ValveBoston Medical Products, Inc.3508012015-09-20
EBES3508021Montgomery® Cannula Speaking ValveBoston Medical Products, Inc.3508022015-09-20
EBES3510011Montgomery® Cannula Speaking ValveBoston Medical Products, Inc.3510012015-09-20
EBES3510021Montgomery® Cannula Speaking ValveBoston Medical Products, Inc.3510022015-09-20
00866035000305Shikani Speaking Valve Airway Company, TheSSV-C2019-05-24
00866035000312Shikani Speaking ValveAirway Company, TheSSV-B2019-05-24
50884522005362ShileyCovidien LPSSV2015-09-02
50884522005379ShileyCovidien LPSSVO2015-09-02
40884522007734ShileyCovidien LPSSVO2015-10-12
60884522007721ShileyCovidien LPSSV2015-09-02
07331791002885Provox® FreeHands HME®Atos Medical AB77102016-09-11
07331791002915Provox® FreeHands HME® Speech Valve Membrane LightAtos Medical ABLight2016-09-11
07331791002922Provox® FreeHands HME® Speech Valve Membrane MediumAtos Medical ABMedium2016-09-11
07331791002939Provox® FreeHands HME® Speech Valve Membrane StrongAtos Medical ABStrong2016-09-11
07331791002946Provox® FreeHands HME® Replacement Device LightAtos Medical AB77162016-09-11
07331791002953Provox® FreeHands HME® Replacement Device MediumAtos Medical ABMedium2016-09-11
07331791002960Provox® FreeHands HME® Cleaning and Storage BoxAtos Medical AB77182016-09-11
07331791002977Provox® FreeHands HME® Adjustment KitAtos Medical AB77192016-09-11
07331791002991Provox® FreeHands HME® Replacement Device StrongAtos Medical ABStrong2016-09-11
07331791003004Provox® FreeHands HME® Replacement DeviceAtos Medical AB77222016-09-11
07331791008184ProTrach® DualCare™ Set 22Atos Medical AB77402016-09-27
07331791008191ProTrach® DualCare™ Set 15Atos Medical AB77412016-09-27
07331791008207ProTrach® HME 15 RegularAtos Medical AB77422016-09-27
07331791008214ProTrach® DualCare™ Speaking ValveAtos Medical AB77442016-09-27
07331791008245ProTrach® HME 22 RegularAtos Medical AB77472016-09-27
07331791008276Provox FreeHands FlexiVoice Set PlusAtos Medical AB77572016-09-11
07331791008283Provox FreeHands FlexiVoice SetAtos Medical AB77602016-09-11
07331791008290Provox FreeHands FlexiVoice LightAtos Medical AB81612016-09-11