A flexible, form-shaped device that is placed over the nose and mouth to deliver aerosolized particles/gases to a patient's airway. It is typically used in conjunction with a nebulizer or medicine chamber spacer for the delivery of medication in either a healt
| Company | Devices | Share |
|---|---|---|
| Sunset Healthcare Solutions, Inc. | 38 | 30% |
| Medline Industries, Inc. | 11 | 9% |
| Respironics Respiratory Drug Delivery (Uk) Ltd | 10 | 8% |
| Twin Med, Llc | 7 | 6% |
| Flexicare Medical Limited | 6 | 5% |
| Teleflex Incorporated | 6 | 5% |
| Medi/Nuclear Corporation, Inc. | 5 | 4% |
| Mediox Medical Service Ltd | 5 | 4% |
| Medsource International Llc | 5 | 4% |
| Atomo Dental, Inc. | 4 | 3% |
| Icu Medical, Inc. | 4 | 3% |
| Intersurgical Incorporated | 3 | 2% |
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 |
|---|---|---|
| BYG | Mask, Oxygen | 37 |
| BYG | MASK, OXYGEN | 34 |
| BYF | Mask, Oxygen, Low Concentration, Venturi | 16 |
| CAF | Nebulizer (Direct Patient Interface) | 14 |
| BSJ | Mask, Gas, Anesthetic | 5 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 5 |
Use these as the dimensions to specify in a tender line.
125 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Aerosol face mask, rebreathing, single-use", from 22 companies. The largest labeler is Sunset Healthcare Solutions, Inc. with 30% of records.
BYG (Mask, Oxygen), BYG (MASK, OXYGEN), BYF (Mask, Oxygen, Low Concentration, Venturi), CAF (Nebulizer (Direct Patient Interface))
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.