FDA.reportPublic FDA data

CPAP/BPAP nasal mask, single-use

Definition
A non-sterile, flexible, form-shaped device designed to be placed over a user's nose 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 and/or silicone materials that create an airtight seal around the nose. 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
662
Last updated
2026-08-28 10:20:28

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00199972000436CuraplexBOUND TREE MEDICAL, LLC8600-01565-KIT2026-08-15
00606959000735Contour DeluxeRespironics, Inc.Contour Deluxe Mask and Headgear, SPU, Small, INTL2015-10-29
00606959000742Contour DeluxeRespironics, Inc.Contour Deluxe Mask and Headgear, SPU, Med/Large, 2016-02-12
00606959024809Contour DeluxeRespironics, Inc.Contour Deluxe Mask and Headgear, SPU, Medium Larg2016-05-12
00606959024816Contour DeluxeRespironics, Inc.Contour Deluxe Mask and Headgear, SPU, Small, US2016-05-12
00606959024823Contour DeluxeRespironics, Inc.Contour Deluxe Mask and Headgear, SPU, Petite, US/2016-05-12
00606959024830Contour DeluxeRespironics, Inc.Contour Deluxe Mask and Headgear, SPU, Medium Larg2016-05-12
00606959024847Contour DeluxeRespironics, Inc.Contour Deluxe Mask and Headgear, SPU, Small, Chin2016-05-12
00606959024854Contour DeluxeRespironics, Inc.002016-05-12
00606959024861Contour DeluxeRespironics, Inc.Contour Deluxe Mask and Headgear, SPU, Med Large, 2016-05-12
00606959024878Contour DeluxeRespironics, Inc.Contour Deluxe Mask and Headgear, SPU, Small, Kore2016-05-12
00606959024885Contour DeluxeRespironics, Inc.Contour Deluxe Mask w/Headgear, SPU, Petite, KR2016-05-12
00606959027152AP111Respironics, Inc.AP111 Mask w/Headgear, Circuit, Filter, SU, Cradle2016-08-30
00606959041462PN841Respironics, Inc.PN841 Mask, Small Child Small, Leak 3, ASM2016-11-23
00606959041479PN841Respironics, Inc.PN841 Mask, Small Child Med, Leak 3, ASM2016-11-23
00606959041486PN841Respironics, Inc.PN841 Mask, Small Child Large, Leak 3, ASM2016-11-23
00606959041493PN841Respironics, Inc.PN841 Mask, Small Child Small, SE, ASM2016-11-23
00606959041509PN841Respironics, Inc.PN841 Mask, Small Child Med, SE, ASM2016-11-23
00606959041516PN841Respironics, Inc.PN841 Mask, Small Child Large, SE, ASM2016-11-23
00606959041608PN841Respironics, Inc.PN841 Mask, JPN, Child Small, Leak 3, ASM2017-03-14
00606959041615PN841Respironics, Inc.PN841 Mask, JPN, Child Med, Leak 3, ASM2017-03-14
00606959041622PN841Respironics, Inc.PN841 Mask, JPN, Child Large, Leak 3, ASM2017-03-14
00606959041639PN841Respironics, Inc.PN841 Mask, JPN, Child Small, SE, ASM2017-03-14
00606959041646PN841Respironics, Inc.PN841 Mask, JPN, Child Med, SE, ASM2017-03-14
00606959041653PN841Respironics, Inc.PN841 Mask, JPN, Child Large, SE, ASM2017-03-14
00606959041721PN841Respironics, Inc.PN841 Mask, INTL, Child Small, Leak 3, ASM2017-03-14
00606959041738PN841Respironics, Inc.PN841 Mask, INTL, Child Med, Leak 3, ASM2017-03-14
00606959041745PN841Respironics, Inc.PN841 Mask, INTL, Child Large, Leak 3, ASM2017-03-14
00606959041752PN841Respironics, Inc.PN841 Mask, INTL, Child Small, SE, ASM2017-03-14
00606959041769PN841Respironics, Inc.PN841 Mask, INTL, Child Med, SE, ASM2017-03-14
00606959041776PN841Respironics, Inc.PN841 Mask, INTL, Child Large, SE, ASM2017-03-14
00607411942273N/ASALTER LABSCLG52017-09-03
00607411942297N/ASALTER LABSCMP42017-09-03
00607411942303N/ASALTER LABSCSM22017-09-03
00607411942310N/ASALTER LABSCSX12017-09-03
00607411942327N/ASALTER LABSCXL62017-09-03
00607411942334N/ASALTER LABSCXS1P2017-09-03
00607411942358N/ASALTER LABSCMD3P2017-09-03
00607411942365N/ASALTER LABSCMP4P2017-09-03
00607411942372N/ASALTER LABSCLG5P2017-09-03
00810094578008Curaplex®BOUND TREE MEDICAL, LLCSCPAPMD302-24-KIT2025-07-09
00810094578015Curaplex®BOUND TREE MEDICAL, LLCSCPAPMD303-24-KIT2025-07-09
00810094578022Curaplex®BOUND TREE MEDICAL, LLCSGOPAPLG01-24-KIT2025-07-09
00810094578039Curaplex®BOUND TREE MEDICAL, LLCSGOPAPMD01-24-KIT2025-07-09
00810094578046Curaplex®BOUND TREE MEDICAL, LLCSGOPAPMD02-24-KIT2025-07-09
00810094578534Curaplex®BOUND TREE MEDICAL, LLCSCPAPMD301-24-KIT2025-08-06
00814747021897Innova Nasal Non Vented Mask, s/mSLEEPNET, CORP.505922019-04-23
00814747021903Innova Nasal Non Vented Mask, m/lSLEEPNET, CORP.505932019-04-24
00817617024301CuraplexBOUND TREE MEDICAL, LLC710502017-12-22
00817617024318CuraplexBOUND TREE MEDICAL, LLC710512017-07-27
00833224000569Sylent NEInnomed Technologies IncSYL2712016-09-15
00833224000576Sylent NEInnomed Technologies IncSYL2732016-09-15
00833224000842Nasal-Aire IIInnomed Technologies IncCXS1P2016-09-15
00833224000859Nasal-Aire IIInnomed Technologies IncCSM2P2016-09-15
00833224000866Nasal-Aire IIInnomed Technologies IncCMD3P2016-09-15
00833224000873Nasal-Aire IIInnomed Technologies IncCMP4P2016-09-15
00833224000880Nasal-Aire IIInnomed Technologies IncCLG5P2016-09-15
00833224000897Nasal-Aire IIInnomed Technologies IncCXL6P2016-09-15
00833224004000Nasal-Aire IIInnomed Technologies IncCXS12016-09-15
00833224004017Nasal-Aire IIInnomed Technologies IncCSM22016-09-15
00833224004024Nasal-Aire IIInnomed Technologies IncCMD32016-09-15
00833224004031Nasal-Aire IIInnomed Technologies IncCMP42016-09-15
00833224004055Nasal-Aire IIInnomed Technologies IncCXL62016-09-15
00841470105501BiTracPULMODYNE INC101615782025-04-11
00841470105518BiTrac PULMODYNE INC101615772025-04-11
00841470105525BiTracPULMODYNE INC101615792025-04-11
00841470105532BiTracPULMODYNE INC101615762025-04-11
00841470106447BiTracPULMODYNE INC313-9013W2016-10-14
00841470106454BiTracPULMODYNE INC313-9014W2016-09-30
00841470106461BiTracPULMODYNE INC313-9016W2016-09-30
00841470106478BiTrac SE SelectPULMODYNE INC313-9040W2017-04-07
00841470106485BiTrac SE SelectPULMODYNE INC313-9041W2017-04-07
00841470106560BiTrac SE SelectPULMODYNE INC313-9049W2017-04-07
00841470106713BiTrac SE SelectPULMODYNE INC313-9028W2017-04-07
00841470106720BiTrac SE SelectPULMODYNE INC313-9030W2017-04-07
00841470106829BiTrac SE SelectPULMODYNE INC313-9039W2017-04-07
00841470107000BiTracPULMODYNE INC313-9015W2016-09-30
00841470107086BiTrac VentedPULMODYNE INC313-91542017-06-30
00841470107093BiTrac VentedPULMODYNE INC313-91552017-06-30
00841470107109BiTrac VentedPULMODYNE INC313-91562017-06-30