FDA.reportPublic FDA data

CPAP/BPAP oral mask

Definition
A flexible, form-shaped device designed to be fitted to the user's 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 and/or silicone materials that create an airtight seal around the patient's mouth; this providing a solution for mouth breathers and patients with chronic nasal obstruction. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.
GUDID devices
59
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00607411942396N/ASALTER LABSHYB5002017-09-03
00607411942402N/ASALTER LABSHYB5112017-09-03
00607411942419N/ASALTER LABSHYB5132017-09-03
00607411942426N/ASALTER LABSHYB5152017-09-03
00607411942433N/ASALTER LABSHYB5212017-09-03
00607411942440N/ASALTER LABSHYB5232017-09-03
00607411942457N/ASALTER LABSHYB5252017-09-03
00607411942464N/ASALTER LABSHYB5302017-09-03
00607411942471N/ASALTER LABSHYB5402017-09-03
00607411943744N/ASALTER LABSHYB5512017-09-03
00607411943751N/ASALTER LABSHYB5532017-09-03
00607411943768N/ASALTER LABSHYB5552017-09-03
00833224000156HybridInnomed Technologies IncHYB5002016-09-15
00833224000163HybridInnomed Technologies IncHYB5152016-09-15
00833224000170HybridInnomed Technologies IncHYB5132016-09-15
00833224000187HybridInnomed Technologies IncHYB5112016-09-15
00833224000194HybridInnomed Technologies IncHYB5252016-09-15
00833224000200HybridInnomed Technologies IncHYB5232016-09-15
00833224000217HybridInnomed Technologies IncHYB5212016-09-15
00833224000231HybridInnomed Technologies IncHYB5402016-09-15
00833224000255Hybrid AVInnomed Technologies IncHYB5532016-09-15
00833224000262Hybrid AVInnomed Technologies IncHYB5512016-09-15
00833224001160HybridInnomed Technologies IncHYB5102016-09-15
00833224001177HybridInnomed Technologies IncHYB5312016-09-15
00833224001184HybridInnomed Technologies IncHYB5332016-09-15
00833224001191HybridInnomed Technologies IncHYB5352016-09-15
09420012429247Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDHC452A2016-09-08
10788942207479PortexICU MEDICAL, INC.23-07472016-10-11
10788942207578PortexICU MEDICAL, INC.23-07572016-10-11
50788942207477PortexSMITHS MEDICAL ASD, INC.23-07472016-10-11
50788942207576PortexSMITHS MEDICAL ASD, INC.23-07572016-10-11
00833224000248Hybrid AVInnomed Technologies IncHYB5552016-09-15
50833224000151HybridInnomed Technologies IncHYB5002016-09-15
50833224000168HybridInnomed Technologies IncHYB5152016-09-15
50833224000175HybridInnomed Technologies IncHYB5132016-09-15
50833224000182HybridInnomed Technologies IncHYB5112016-09-15
50833224000199HybridInnomed Technologies IncHYB5252016-09-15
50833224000205HybridInnomed Technologies IncHYB5232016-09-15
50833224000212HybridInnomed Technologies IncHYB5212016-09-15
50833224000236HybridInnomed Technologies IncHYB5402016-09-15
50833224000250Hybrid AVInnomed Technologies IncHYB5532016-09-15
50833224000267Hybrid AVInnomed Technologies IncHYB5512016-09-15
50833224001165HybridInnomed Technologies IncHYB5102016-09-15
50833224001172HybridInnomed Technologies IncHYB5312016-09-15
50833224001189HybridInnomed Technologies IncHYB5332016-09-15
50833224001196HybridInnomed Technologies IncHYB5352016-09-15
50788942260007PortexICU MEDICAL, INC.23-60002016-10-11
10607411942393N/ASALTER LABSHYB5002017-09-03
10607411942409N/ASALTER LABSHYB5112017-09-03
10607411942416N/ASALTER LABSHYB5132017-09-03
10607411942423N/ASALTER LABSHYB5152017-09-03
10607411942430N/ASALTER LABSHYB5212017-09-03
10607411942447N/ASALTER LABSHYB5232017-09-03
10607411942454N/ASALTER LABSHYB5252017-09-03
10607411942461N/ASALTER LABSHYB5302017-09-03
10607411942478N/ASALTER LABSHYB5402017-09-03
10607411943741N/ASALTER LABSHYB5512017-09-03
10607411943758N/ASALTER LABSHYB5532017-09-03
10607411943765N/ASALTER LABSHYB5552017-09-03