A non-sterile, 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
| Company | Devices | Share |
|---|---|---|
| Respironics, Inc. | 223 | 30% |
| Pulmodyne Inc | 182 | 24% |
| Sleepnet, Corp. | 114 | 15% |
| Hans Rudolph, Inc. | 84 | 11% |
| Fisher & Paykel Healthcare Limited | 48 | 6% |
| Salter Labs | 16 | 2% |
| B.L.S. Systems Limited | 16 | 2% |
| Innomed Technologies Inc | 15 | 2% |
| O-Two Medical Technologies Inc | 13 | 2% |
| Hmc Premedical Spa | 10 | 1% |
| Galemed Corporation | 5 | 1% |
| Mediox Medical Service Ltd | 5 | 1% |
Company = labeler of record on GUDID. 21 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) | 328 |
| CBK | Ventilator, Continuous, Facility Use | 163 |
| BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 149 |
| CBK | VENTILATOR, CONTINUOUS, FACILITY USE | 109 |
| MNS | VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING | 53 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 30 |
Use these as the dimensions to specify in a tender line.
752 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "CPAP/BPAP face mask, single-use", from 21 companies. The largest labeler is Respironics, Inc. with 30% of records.
BZD (Ventilator, Non-Continuous (Respirator)), CBK (Ventilator, Continuous, Facility Use), BZD (VENTILATOR, NON-CONTINUOUS (RESPIRATOR)), 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.