FDA.reportPublic FDA data

CPAP/BPAP face mask, single-use

Definition
A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
GUDID devices
1,512
Last updated
2026-06-17 06:05:13

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
09420012477477F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDONIV117A2025-12-06
09420012477484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDONIV117B2025-12-06
09420012477491F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDONIV117C2025-12-06
09420012480446F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDONIV117A-F2025-12-06
09420012480460F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDONIV117B-F2025-12-06
09420012480484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDONIV117C-F2025-12-06
00606959000636PERFORMATRAKRespironics, Inc.PerformaTrak Mask with Headgear, Disposable, Small2016-05-12
00606959000643PERFORMATRAKRespironics, Inc.PerformaTrak Mask with Headgear, Disposable, Mediu2016-05-12
00606959000650PERFORMATRAKRespironics, Inc.PerformaTrak Mask with Headgear, Disposable, Large2016-05-12
00606959000698PERFORMATRAKRespironics, Inc.PerformaTrak SE Mask w/Headgear, Disp, Small, USA2016-05-12
00606959000704PERFORMATRAKRespironics, Inc.PerformaTrak SE Mask w/Headgear, Disp, Medium, USA2016-05-12
00606959000711PERFORMATRAKRespironics, Inc.PerformaTrak SE Mask w/Headgear, Disp, Large, USA2016-05-12
00606959000858PerforMaxRespironics, Inc.PerforMax Mask, Single Patient Use, EE, INTL, Smal2016-09-23
00606959000865PerforMaxRespironics, Inc.PerforMax Mask, Single Patient Use, EE, INTL, Larg2016-09-23
00606959000872PerforMaxRespironics, Inc.PerforMax Mask with SE, Single Patient Use, INTL, 2016-09-23
00606959000889PerforMaxRespironics, Inc.PerforMax Mask with SE, Single Patient Use, INTL, 2016-09-23
00606959003279PerformatrakRespironics, Inc.PERFORMATRAK FULL w CAPSTRAP,SMALL2016-05-23
00606959003286PerformatrakRespironics, Inc.PERFORMATRAK FULL w CAPSTRAP, MEDIUM2016-05-23
00606959003293PerformaTrakRespironics, Inc.PERFORMATRAK FULL FACE MASK WITH CAP STRAP, LARGE2016-05-23
00606959004078PerforMaxRespironics, Inc.PerforMax Mask with EE, Single Patient Use, Small,2016-09-23
00606959004085PerforMaxRespironics, Inc.PerforMax Mask with EE, Single Patient Use, Large,2016-09-23
00606959004559AF531Respironics, Inc.AF531 Mask EE, LEAK 1, with 4 PT Headgear, Small, 2016-06-10
00606959004566AF531Respironics, Inc.AF531 Mask EE, LEAK 1, with 4 PT Headgr, Medium, S2016-06-10
00606959004573AF531Respironics, Inc.AF531 Mask EE, LEAK 1, with 4 PT Headgear, Large, 2016-06-10
00606959004580AF531Respironics, Inc.AF531 Mask EE, LEAK 1, with CapStrap, Small, Singl2016-06-10
00606959004597AF531Respironics, Inc.AF531 Mask EE, LEAK 1, with CapStrap, Medium, Sing2016-06-10
00606959004603AF531Respironics, Inc.AF531 Mask EE, LEAK 1, with CapStrap, Large, Singl2016-06-10
00606959007307AF531Respironics, Inc.A531 Mask EE, LEAK1, Nebulizing Elbow, w/CapStrap,2016-06-10
00606959007314AF531Respironics, Inc.A531 Mask EE, LEAK1, Neb Elbow, w/CapStrap, Med, S2016-06-10
00606959007321AF531Respironics, Inc.A531 Mask EE, LEAK1, Nebulizing Elbow, W/CapStrap,2016-06-10
00606959007338AF531Respironics, Inc.AF531 Mask w/SE, Nebulizing Elbow, w/CapStrap, Sma2016-06-10
00606959007345AF531Respironics, Inc.AF531 Mask w/SE, Nebulizing Elbow, w/CapStrap, Med2016-06-10
00606959007352AF531Respironics, Inc.006069590073522016-06-10
00606959007369AF531Respironics, Inc.AF531 Mask EE, Leak 2, with W/CapStrap, Small, SU2016-06-10
00606959007376AF531Respironics, Inc.AF531 Mask EE, Leak 2, w/CapStrap, Medium, SU2016-06-10
00606959007383AF531Respironics, Inc.AF531 Mask EE, Leak 2, w/CapStrap, Large, SU2016-06-10
00606959007482AF531Respironics, Inc.AF531Mask EE, Leak 1, Neb Elbow, w/4 PT Headgr, Sm2016-06-10
00606959007499AF531Respironics, Inc.AF531Mask EE, Leak 1, Neb Elbow, w/4 PT Headgr, Me2016-06-10
00606959007505AF531Respironics, Inc.AF531Mask EE, Leak 1, Neb Elbow, 4 PT Headgr, Larg2016-06-10
00606959007543PERFORMATRAKRespironics, Inc.PERFORMATRAK FULL SE W CAPSTRAP, SMALL2016-05-23
00606959007550PERFORMATRAKRespironics, Inc.PERFORMATRAK FULL SE W CAPSTRAP, MEDIUM2016-05-23
00606959007567PERFORMATRAKRespironics, Inc.PERFORMATRAK FULL SE W CAPSTRAP, LARGE2016-05-23
00606959007574PERFORMATRAKRespironics, Inc.Performatrak Mask with Headgear, Small, Disposable2016-05-12
00606959007581PERFORMATRAKRespironics, Inc.Performatrak Mask w/Headgear, Medium, Disposable, 2016-05-12
00606959007598PERFORMATRAKRespironics, Inc.Performatrak Mask w/ Headgear, Large, Disposable, 2016-05-12
00606959007604PERFORMATRAKRespironics, Inc.Performatrak Mask with SE and Headgr, Small, Disp,2016-05-12
00606959007611PERFORMATRAKRespironics, Inc.Performatrak Mask w/SE and Headgr, Med, Disp, INTL2016-05-12
00606959007628PERFORMATRAKRespironics, Inc.Performatrak Mask w/SE and Headgr, Large, Disp, IN2016-05-12
00606959007734PERFORMAXRespironics, Inc.PERFORMAX Mask with EE, Leak 2, XSmall, Single Use2019-03-04
00606959007741PERFORMAXRespironics, Inc.PERFORMAX Mask with EE, Leak 2, XXSmall, Single Us2019-03-04
00606959007765PERFORMAXRespironics, Inc.PERFORMAX Mask with SE, XXSmall, Single Use2019-03-04
00606959007833Nebulizing ElbowRespironics, Inc.Entrainment Elbow Nebulizing Elbow Kit2016-09-18
00606959007857Bronchoscopy ElbowRespironics, Inc.Bronchoscopy Elbow2016-10-04
00606959008083AF531Respironics, Inc.AF531 Mask EE, Leak 1, Circuit, Neb Elbow, CapStra2016-06-10
00606959008090AF531Respironics, Inc.AF531 Mask EE, Leak 1, Circuit, Neb Elbow, CapStra2016-06-10
00606959008106AF531Respironics, Inc.AF531Mask EE, Leak 1, Circuit, Neb Elbow, CapStrap2016-06-10
00606959008113AF531Respironics, Inc.AF531 Mask EE, Leak 1, Circuit with 4 PT Headgr, S2016-06-10
00606959008120AF531Respironics, Inc.AF531 Mask EE, Leak 1, Circuit with 4 PT Headgr, M2016-06-10
00606959008137AF531Respironics, Inc.AF531 Mask EE, Leak 1, Circuit with 4 PT Headgr, L2016-06-10
00606959008298Nebulizing ElbowRespironics, Inc.Standard Elbow, Nebulizing Elbow Kit2016-09-18
00606959008304AF421Respironics, Inc.AF421 Mask with Entrainment Elbow, Leak 1 , Small,2015-11-06
00606959008311AF421Respironics, Inc.AF421 Mask with Entrainment Elbow, Leak 1 , Medium2015-11-06
00606959008328AF421Respironics, Inc.AF421 Mask, with Entrainment Elbow, Leak 1, Large,2015-11-06
00606959008335AF421Respironics, Inc.AF421 Mask with Entrainment Elbow, Leak 1 , Extra 2015-11-06
00606959008380AF421Respironics, Inc.AF421 Mask with Entrainment Elbow, Leak 1, Small, 2015-11-13
00606959008397AF421Respironics, Inc.AF421 Mask with Entrainment Elbow, Leak 1, Medium,2015-11-13
00606959008403AF421Respironics, Inc.AF421 Mask with Entrainment Elbow, Leak 1, Large, 2015-11-13
00606959008410AF421Respironics, Inc.AF421 Mask with Entrainment Elbow, Leak 1, XLarge,2015-11-13
00606959008465AF421Respironics, Inc.AF421 Mask with Standard Elbow, Small, Global2015-11-13
00606959008472AF421Respironics, Inc.AF421 Mask with Standard Elbow, Medium, Global2015-11-13
00606959008489AF421Respironics, Inc.AF421 Mask with Standard Elbow, Large, Global2015-11-13
00606959008496AF421Respironics, Inc.AF421 Mask with Standard Elbow, Extra Large, Globa2016-02-16
00606959008540AF421Respironics, Inc.AF421 Mask with Entrainment Elbow, Leak 2, Small, 2015-11-16
00606959008557AF421Respironics, Inc.AF421 Mask with Entrainment Elbow, Leak 2, Medium,2015-11-16
00606959008564AF421Respironics, Inc.AF421 Mask with Entrainment Elbow, Leak 2, Large, 2015-11-16
00606959008571AF421Respironics, Inc.AF421 Mask with Entrainment Elbow, Leak 2, XLarge,2015-11-13
00606959008687AF531Respironics, Inc.AF531 Mask w/SE, w/4 PT Headgear, SU, Small, CN2016-02-12
00606959008694AF531Respironics, Inc.AF531 Mask w/SE, 4 PT Headgear, SU, Medium, CN2016-02-12
00606959008700AF531Respironics, Inc.AF531 Mask w/SE, w/4 PT Headgear, SU, Large, CN2016-02-12
00606959008779Nebulizing ElbowRespironics, Inc.EE Nebulizing Elbow Kit, Single, CN2016-09-18