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Device Explorer · FDA GUDID · GMDN 43947

Positive pressure airway secretion-clearing device

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

US‑registered devices89in commercial distribution
Companies15labelers on GUDID
Single‑use18%of device records
Sterile0%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Respironics, Inc.4348%
Icu Medical, Inc.1719%
Breas Medical Ab67%
Tri-Anim Health Services, Inc.56%
Medical Acoustics Llc33%
Trudell Medical International33%
Pari Respiratory Equipment, Inc.33%
Respironics Respiratory Drug Delivery (Uk) Ltd22%

Top labelers

CompanyDevicesShare
Respironics, Inc.4348%
Icu Medical, Inc.1719%
Breas Medical Ab67%
Tri-Anim Health Services, Inc.56%
Medical Acoustics Llc33%
Trudell Medical International33%
Pari Respiratory Equipment, Inc.33%
Respironics Respiratory Drug Delivery (Uk) Ltd22%
Besmed Health Business Corp.11%
Bound Tree Medical, Llc11%
Monaghan Medical Corporation11%
Thayer Medical Corporation11%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ClearoClearo Patient Circuit AmericasDeMucus™ Expiratory Muscle TrainerCuraplexLung Flute® TherapeuticLung Flute® for Home CareLung Flute® for Hospitals & ClinicsAEROBIKA OPEP with ManometerAEROBIKA OPEP ManometerAEROBIKA Oscillating Positive Expiratory PressurLCO-PEPPEP-SCoughAssistATOSAerobika,OPEP

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
NHJDEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT47
BWFSPIROMETER, THERAPEUTIC (INCENTIVE)29
BWFSpirometer, Therapeutic (Incentive)15
NHJDevice, Positive Pressure Breathing, Intermittent7
BZOSET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)5
BYIPercussor, Powered-Electric4

GMDN & GCC registration

  • GMDN code 43947 · non‑implantable
  • Single‑use 18% · sterile 0% · Rx‑only 99% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many positive pressure airway secretion-clearing device products are registered in the US?

89 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Positive pressure airway secretion-clearing device", from 15 companies. The largest labeler is Respironics, Inc. with 48% of records.

Which FDA product codes apply?

NHJ (DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT), BWF (SPIROMETER, THERAPEUTIC (INCENTIVE)), BWF (Spirometer, Therapeutic (Incentive)), NHJ (Device, Positive Pressure Breathing, Intermittent)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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