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Device Explorer · FDA GUDID · GMDN 63172

CPAP/BPAP unit ambient air filter, reusable

A non-sterile filter designed to be installed in a continuous positive airway pressure (CPAP) and/or bi-level positive airway pressure (BPAP) unit to filter particulates from the ambient air prior to inhalation; it is not intended to filter medical gases. It i

US‑registered devices476in commercial distribution
Companies4labelers on GUDID
Single‑use12%of device records
Sterile0%labelled sterile
Prescription1%Rx‑only share
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Share of device records

Sunset Healthcare Solutions, Inc.47299%
D R Burton Healthcare, Llc20%
Telesair, Inc.10%
Fresca Medical, Inc.10%

Top labelers

CompanyDevicesShare
Sunset Healthcare Solutions, Inc.47299%
D R Burton Healthcare, Llc20%
Telesair, Inc.10%
Fresca Medical, Inc.10%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Bonhawa Air FilterOxyTrainer ADVANTAGEOxyBREATH NON-MEASURING EXERCISERCPAP FilterOxygen, Bacteria & HEPA FilterVENTILATOR FILTERCPAP FiltersVentilator FilterPhilips Respironics DreamStation 2 Style ReusablPhilips Respironics DreamStation Style Reusable 3B Luna G3 CPAP Reusable FilterUltra Fine Filter Compatible w/ Healthdyne TranqLöwenstein LUISA Ventilator and prisma Style ReuF&P Sleepstyle CPAP filterResmed Airsense 11 CPAP FilterPhilips Respironics DreamStation 2 Style Disposa

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

FDA product codes

CodeNameDevices
JRLUnit, Filter, Membrane458
CAHFilter, Bacterial, Breathing-Circuit8
IONExerciser, Non-Measuring2
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)1
QBYPositive Airway Pressure System1

GMDN & GCC registration

  • GMDN code 63172 · non‑implantable
  • Single‑use 12% · sterile 0% · Rx‑only 1% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Lumen/Inner Diameter (Millimeter) · 10Outer Diameter (Millimeter) · 5

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

How many cpap/bpap unit ambient air filter, reusable products are registered in the US?

476 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "CPAP/BPAP unit ambient air filter, reusable", from 4 companies. The largest labeler is Sunset Healthcare Solutions, Inc. with 99% of records.

Which FDA product codes apply?

JRL (Unit, Filter, Membrane), CAH (Filter, Bacterial, Breathing-Circuit), ION (Exerciser, Non-Measuring), BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))

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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