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
| Company | Devices | Share |
|---|---|---|
| Sunset Healthcare Solutions, Inc. | 453 | 99% |
| Bound Tree Medical, Llc | 5 | 1% |
Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| JRL | Unit, Filter, Membrane | 447 |
| BYE | Attachment, breathing, positive end expiratory pressure | 5 |
| BYX | Tubing, Pressure And Accessories | 2 |
| CAH | Filter, Bacterial, Breathing-Circuit | 2 |
Use these as the dimensions to specify in a tender line.
458 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, single-use", from 2 companies. The largest labeler is Sunset Healthcare Solutions, Inc. with 99% of records.
JRL (Unit, Filter, Membrane), BYE (Attachment, breathing, positive end expiratory pressure), BYX (Tubing, Pressure And Accessories), CAH (Filter, Bacterial, Breathing-Circuit)
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.