FDA.reportPublic FDA data

Positive pressure airway secretion-clearing device

Definition
A hand-held, non-powered device designed to remove excessive mucus or sputum (phlegm) from the lungs and upper airways using positive pressure airway (PEP) to treat patients affected by acute or chronic lung disease. PEP is created when a patient exhales into the device which creates vibrations in the chest by various means (e.g., an oscillating ball or creating bubbles in a solution within the device) loosening the mucus for expectoration and assisting in lung expansion. Also known as an oscillating positive expiratory pressure (OPEP) device, it is a single-patient device designed for use both in a healthcare facility and in the home. This is a reusable device.
GUDID devices
64
Last updated
2026-10-15 14:55:12

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810094573072CuraplexBOUND TREE MEDICAL, LLC301-44F10-1202022-04-30
00810094573089CuraplexBOUND TREE MEDICAL, LLC301-44F50-1002022-04-30
00812277032024CuraplexBOUND TREE MEDICAL, LLC301-44F50-1002018-12-15
00812277032055CuraplexBOUND TREE MEDICAL, LLC301-44F10-1202018-12-15
00812574022032CuraplexTRI-ANIM HEALTH SERVICES, INC.301-44F50-1002016-12-14
00818834020343CuraplexTRI-ANIM HEALTH SERVICES, INC.301-44F10-1202017-04-18
00818834020350CuraplexTRI-ANIM HEALTH SERVICES, INC.301-122182017-04-18
00818834028134CuraplexTRI-ANIM HEALTH SERVICES, INC.301-122182019-07-01
00383480000068QUAKETHAYER MEDICAL CORPORATION12972016-09-21
00604351505124Aerobika,OPEP Monaghan Medical CorporationAerobika, OPEP Device, Retail2024-05-16
00744229180128PEP-SPARI RESPIRATORY EQUIPMENT, INC.018F632016-09-30
00744229180142O-PEPPARI RESPIRATORY EQUIPMENT, INC.018F652017-06-30
00744229410881LCPARI RESPIRATORY EQUIPMENT, INC.041F35002016-11-17
00762860105027AEROBIKA OPEP ManometerTrudell Medical International1105022020-04-22
00762860105041AEROBIKA OPEP with ManometerTrudell Medical International1105042020-02-18
00810094575021CuraplexBOUND TREE MEDICAL, LLC301-670255-KIT2023-02-28
00812574029949CuraplexTRI-ANIM HEALTH SERVICES, INC.301-T1012017-06-20
00812574029970CuraplexTRI-ANIM HEALTH SERVICES, INC.301-T1022017-06-20
00816133010003Lung Flute® for Hospitals & ClinicsMEDICAL ACOUSTICS LLC1004-012017-01-31
00816133010010Lung Flute® for Home CareMEDICAL ACOUSTICS LLC1003-012017-01-31
00816133010089Lung Flute® TherapeuticMEDICAL ACOUSTICS LLC1005-012017-01-31
00818834020008CuraplexTRI-ANIM HEALTH SERVICES, INC.301-T1032017-06-20
00818834028615CuraplexTRI-ANIM HEALTH SERVICES, INC.301-44F10-1202024-03-10
00818834028622CuraplexTRI-ANIM HEALTH SERVICES, INC.301-44F50-1002024-03-10
07321820104666Clearo Patient Circuit AmericasBreas Medical AB0104662025-11-03
10788942210158PortexICU MEDICAL, INC.21-10152016-10-11
10788942215306PortexICU MEDICAL, INC.21-15302016-10-11
10788942220058PortexICU MEDICAL, INC.27-00502016-10-11
10788942270008PortexICU MEDICAL, INC.27-70002016-10-11
10788942270015PortexICU MEDICAL, INC.27-70012021-04-06
10788942270114PortexICU MEDICAL, INC.27-7000CN2016-10-11
10788942290006PortexICU MEDICAL, INC.27-90002016-10-11
10788942290013PortexICU MEDICAL, INC.27-90012016-10-11
15019517123098PORTEXICU MEDICAL, INC.27-80002021-03-12
15019517128291PORTEXICU MEDICAL, INC.27-80502021-04-07
15019517183399PortexICU MEDICAL, INC.HCS2770002019-05-16
07321822320002ClearoBreas Medical AB2320002026-02-17
05060405720083ClearoBreas Medical AB2320002025-11-03
07321820081691ClearoBreas Medical AB0081692025-11-03
07321820082834ClearoBreas Medical AB0082832025-11-03
07321820090655ClearoBreas Medical AB0090652025-11-03
07321820090662ClearoBreas Medical AB0090662025-11-03
07321820106226Clearo Patient Circuit AmericasBreas Medical AB0104662025-11-03
08809517011064Comfort CoughSeoil Pacific Corp.SICC20012025-02-19
50604351505129Aerobika,OPEP Monaghan Medical CorporationAerobika, OPEP Device, Retail2024-05-16
00818834028646CuraplexTRI-ANIM HEALTH SERVICES, INC.301-44F10-1202024-03-10
00818834028684CuraplexTRI-ANIM HEALTH SERVICES, INC.301-44F50-1002024-03-10
B99893699980215050AirPhysioAIRPHYSIO PTY. LTD.12024-01-22
00810094575496CuraplexBOUND TREE MEDICAL, LLC301-670255-KIT2023-02-28
00810094573119CuraplexBOUND TREE MEDICAL, LLC301-44F10-1202022-04-30
00810094573126CuraplexBOUND TREE MEDICAL, LLC301-44F50-1002022-04-30
10788942230156PortexICU MEDICAL, INC.21-30152016-10-11
10788942235304PortexICU MEDICAL, INC.21-35302016-10-11
10788942250154PortexICU MEDICAL, INC.21-50152016-10-11
10788942255302PortexICU MEDICAL, INC.21-55302016-10-11
10788942270152PortexICU MEDICAL, INC.21-70152016-10-11
10788942275300PortexICU MEDICAL, INC.21-75302016-10-11
50788942210156PortexSMITHS MEDICAL ASD, INC.21-10152016-10-11
50788942215304PortexSMITHS MEDICAL ASD, INC.21-15302016-10-11
50788942220056PortexSMITHS MEDICAL ASD, INC.27-00502016-10-11
50788942270006PortexSMITHS MEDICAL ASD, INC.27-70002016-10-11
50788942270112PortexSMITHS MEDICAL ASD, INC.27-7000CN2016-10-11
50788942290004PortexSMITHS MEDICAL ASD, INC.27-90002016-10-11
50788942290011PortexSMITHS MEDICAL ASD, INC.27-90012016-10-11