A flexible, form-shaped device designed to be placed over a user's nose and 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 medic
| Company | Devices | Share |
|---|---|---|
| Resmed Pty Ltd | 435 | 33% |
| Sunset Healthcare Solutions, Inc. | 189 | 14% |
| Respironics, Inc. | 150 | 11% |
| Sleepnet, Corp. | 129 | 10% |
| Hans Rudolph, Inc. | 122 | 9% |
| Fisher & Paykel Healthcare Limited | 63 | 5% |
| Bmc Medical Co., Ltd. | 54 | 4% |
| Suzhou Yuyue Medical Technology Co., Ltd. | 37 | 3% |
| Drive Devilbiss Healthcare | 37 | 3% |
| Wellell Inc. | 33 | 3% |
| Innomed Technologies Inc | 13 | 1% |
| Shenzhen Sany Pioneer Technology Co.,Ltd | 10 | 1% |
Company = labeler of record on GUDID. 22 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 |
|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 979 |
| BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 171 |
| CBK | Ventilator, Continuous, Facility Use | 136 |
| CBK | VENTILATOR, CONTINUOUS, FACILITY USE | 62 |
| BYG | Mask, Oxygen | 34 |
| BSJ | Mask, Gas, Anesthetic | 16 |
Use these as the dimensions to specify in a tender line.
1,312 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "CPAP/BPAP face mask, reusable", from 22 companies. The largest labeler is Resmed Pty Ltd with 33% of records.
BZD (Ventilator, Non-Continuous (Respirator)), BZD (VENTILATOR, NON-CONTINUOUS (RESPIRATOR)), CBK (Ventilator, Continuous, Facility Use), CBK (VENTILATOR, CONTINUOUS, FACILITY USE)
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.