FDA.reportPublic FDA data

Tracheostomy mask, aerosol

Definition
A device designed to deliver air, oxygen, or a mixture of the two gases with aerosolized water particles to a patient who has a tracheostomy airway. It is typically connected to an oxygen source and nebulizer with wide bore tubing and is constructed of plastic. The device can be used over a tracheostomy tube or a stoma and is secured with a strap. This is a single-use device.
GUDID devices
42
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00709078009136CirculaireWESTMED, INC.02902020-08-31
00709078009143CirculaireWESTMED, INC.02962020-08-31
00840155400306MedSource Tracheostomy MaskMEDSOURCE INTERNATIONAL LLCMS-251002021-05-28
00840155411623MedSource Tracheostomy MaskMEDSOURCE INTERNATIONAL LLCMS-25210-U2021-10-29
00850108006882Trach O-LifeCUTTING EDGE HC BRANDS LLCRTG-040162019-02-25
00850108006899Trach O-LifeCUTTING EDGE HC BRANDS LLCRTG-040172019-02-25
04026704387571HUDSON RCITELEFLEX INCORPORATEDIPN0413102018-09-15
04026704389636HUDSON RCITELEFLEX INCORPORATEDIPN0443772018-09-15
04026704594306HUDSON RCITELEFLEX INCORPORATEDIPN0413112018-09-15
05030267052035TRACHEOSTOMY MASK, PAEDIATRICIntersurgical Incorporated12060002025-04-15
05030267100552INTERSURGICAL ECOLITE ADULT TRACHEOSTOMY MASKIntersurgical Incorporated12000502021-10-11
10080196193066MedlineMEDLINE INDUSTRIES, INC.HCS245E2023-06-08
10190752116436AirLife™VYAIRE MEDICAL, INC.0012272020-01-15
10190752142046Vital Signs™VYAIRE MEDICAL, INC.0012252021-11-08
10190752142060Vital Signs™VYAIRE MEDICAL, INC.0012262021-11-08
10704411008217AMSure® Tracheostomy MaskAMSINO INTERNATIONAL, INC.12018-06-18
10704411008224AMSure® Tracheostomy MaskAMSINO INTERNATIONAL, INC.12018-06-18
10889483229934Circulaire™SUNMED, LLC02902025-12-31
10889483569412Vital Signs™AIRLIFE0012252025-02-19
10889483569429Vital Signs™AIRLIFE0012262025-02-25
10889483569436AirLife™AIRLIFE0012272025-02-19
14026704648150HUDSON RCITELEFLEX INCORPORATEDIPN0497622025-07-03
20889483229931Circulaire™SUNMED, LLC02902025-12-31
24026704648157HUDSON RCITELEFLEX INCORPORATEDIPN0497622025-07-03
05030267001804TRACHEOSTOMY MASK, PAEDIATRICIntersurgical Incorporated12060002025-04-15
30889483569423Vital Signs™Sunmed Group Holdings, LLC0012262025-02-25
30889483569416Vital Signs™Sunmed Group Holdings, LLC0012252025-02-19
30889483569430AirLife™Sunmed Group Holdings, LLC0012272025-02-19
40080196193067MedlineMEDLINE INDUSTRIES, INC.HCS245E2023-06-08
50190752142044Vital Signs™VYAIRE MEDICAL, INC.0012252021-11-08
50190752142068Vital Signs™VYAIRE MEDICAL, INC.0012262021-11-08
00840155400368MedSource Tracheostomy MaskMEDSOURCE INTERNATIONAL LLCMS-25210-U2021-10-29
05030267100569INTERSURGICAL ECOLITE ADULT TRACHEOSTOMY MASKINTERSURGICAL INCORPORATED12000502021-10-11
10709078009133CirculaireWESTMED, INC.02902020-08-31
10709078009140CirculaireWESTMED, INC.02962020-08-31
50822383138126DRIVEDrive Devilbiss HealthcareMASK 007A2020-02-01
24026704387575HUDSON RCITELEFLEX INCORPORATEDIPN0413102018-09-15
24026704389630HUDSON RCITELEFLEX INCORPORATEDIPN0443772018-09-15
24026704594300HUDSON RCITELEFLEX INCORPORATEDIPN0413112018-09-15
50190752116434AirLife™VYAIRE MEDICAL, INC.0012272020-01-15
10850108006889Trach O-LifeCUTTING EDGE HC BRANDS LLCRTG-040162019-02-25
10850108006896Trach O-LifeCUTTING EDGE HC BRANDS LLCRTG-040172019-02-25