FDA.reportPublic FDA data

Aerosol face mask, rebreathing

Definition
A flexible, form-shaped device that is placed over the nose and mouth to deliver aerosolized particles/gases to a patient's airway. It is typically used in conjunction with a nebulizer or medicine chamber spacer for the delivery of medication in either a healthcare or home setting. It is made of high-grade resins or other materials to produce a soft, flexible mask that will create an airtight seal against the patient's face. It may include a headstrap and is available in a range of sizes. This is a single-use device.
GUDID devices
44
Last updated
2020-08-31 07:20:54

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10193489003147MedlineMEDLINE INDUSTRIES, INC.HCS10798302020-08-21
10193489012804MedlineMEDLINE INDUSTRIES, INC.HCS4632BCT2020-08-21
10888277669178MedlineMEDLINE INDUSTRIES, INC.HCS4632B2020-08-21
04719874690076POCKET AIRMICROBASE TECHNOLOGY CORP.MBPN002032020-06-03
14719874690080POCKET AIRMICROBASE TECHNOLOGY CORP.MBPN002042020-06-03
05055931102182Adult Maxineb Duo Closed System MaskFLEXICARE MEDICAL LIMITED032-10-056U2020-03-27
05055931102199Adult Aerosol Mask W/ Maxineb Duo L-ConnectorFLEXICARE MEDICAL LIMITED032-10-057U2020-03-27
05055931102274Pediatric Maxineb Duo MaskFLEXICARE MEDICAL LIMITED032-10-086U2020-03-27
05055931102298Pediatric Maxineb Duo Closed System MaskFLEXICARE MEDICAL LIMITED032-10-087U2020-03-27
05055788758884Paediatric Aerosol Face MaskFLEXICARE MEDICAL LIMITED032-10-010U2020-01-28
05055788759270Adult Aerosol Face MaskFLEXICARE MEDICAL LIMITED032-10-006U2020-01-28
24026704387537HUDSON RCITELEFLEX INCORPORATEDIPN0443792018-09-15
24026704387582HUDSON RCITELEFLEX INCORPORATEDIPN0413322018-09-15
24026704594331HUDSON RCITELEFLEX INCORPORATEDIPN0413232018-09-15
24026704594348HUDSON RCITELEFLEX INCORPORATEDIPN0413422018-09-15
24026704594355HUDSON RCITELEFLEX INCORPORATEDIPN0413442018-09-15
24026704648171HUDSON RCITELEFLEX INCORPORATEDIPN0497642019-05-09
24026704648188HUDSON RCITELEFLEX INCORPORATEDIPN0497652019-05-09
24026704648195HUDSON RCITELEFLEX INCORPORATEDIPN0497662019-05-09
24026704648201HUDSON RCITELEFLEX INCORPORATEDIPN0497672019-05-09
00822383132341DriveDrive Devilbiss HealthcareMASK 001A2017-05-19
10848530060784Sunset Healthcare Solutions Disposable Nebulizer Kit w/Aerosol MaskSUNSET HEALTHCARE SOLUTIONS, INC.RES0902016-09-24
10848530060975Adult Aerosol MaskSUNSET HEALTHCARE SOLUTIONS, INC.RES21102018-09-19
10848530060982Tracheostomy Mask w/ O2 connector - AdultSUNSET HEALTHCARE SOLUTIONS, INC.RES21302018-09-19
10848530061026Pediatric Aerosol MaskSUNSET HEALTHCARE SOLUTIONS, INC.RES22102018-09-24
00857863007543Aero/Vent PlusMedi/Nuclear Corporation, Inc.MN50452017-06-09
00857863007550Aero/Vent PlusMedi/Nuclear Corporation, Inc.MN71102017-06-09
00857863007642HealthlineMedi/Nuclear Corporation, Inc.MN40462017-06-09
00709078000706Circulaire II Aerosol Drug Delivery SystemWESTMED, INC.03952016-12-11
10709078000802Circulaire Aerosol Drug Delivery SystemWESTMED, INC.03202016-11-24
00349502208027Easivent Mask - MediumMylan Specialty L.P.49502-208-022018-04-10
00349502208034Easivent Mask - LargeMylan Specialty L.P.49502-208-032018-04-10
30349502208011Easivent Mask - SmallMYLAN SPECIALTY L.P.49502-208-012018-04-10
00372217000013Pro-Care Nebulizer EasyARISE MEDICAL LLCEasy2018-12-01
00383730003948System 22RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD002017-08-30
00383730004211SYSTEM 22RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD002017-04-19
00383730004235System 22RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD002017-04-19
00383730004242System 22RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD002017-04-19
00383730004259SYSTEM 22RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD02017-04-19
00383730004266System 22RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD002017-04-19
00383730004273System 22RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD002017-04-19
00383730004280System 22RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD002017-04-19
00383730004327System 22RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD002017-06-28
00383730004365System 22RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD002017-08-30