A non-sterile, form-shaped, fenestrated device designed to be placed over the nose and mouth to deliver a near-precise mixture of air and oxygen (O2) to a patient's airway without the use of a gas mixer. It incorporates a pin/diffuser intended to create vortic
| Company | Devices | Share |
|---|---|---|
| Southmedic Incorporated | 44 | 88% |
| Galemed Xiamen Co., Ltd. | 3 | 6% |
| Airlife | 3 | 6% |
Company = labeler of record on GUDID. 3 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 | 38 |
| CAF | NEBULIZER (DIRECT PATIENT INTERFACE) | 17 |
| KGB | Mask, Oxygen, Non-Rebreathing | 3 |
| BYG | Mask, Oxygen | 3 |
| CAT | CANNULA, NASAL, OXYGEN | 2 |
Use these as the dimensions to specify in a tender line.
50 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Vortex oxygen face mask", from 3 companies. The largest labeler is Southmedic Incorporated with 88% of records.
BYG (MASK, OXYGEN), CAF (NEBULIZER (DIRECT PATIENT INTERFACE)), KGB (Mask, Oxygen, Non-Rebreathing), BYG (Mask, Oxygen)
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.