A flexible, form-shaped device that is placed over a patient's nose and mouth to direct ambient air, or medical oxygen (O2) and air, from a resuscitator to the upper airway and lungs. It is typically made of non-conductive sterilizable materials (e.g., silicon
| Company | Devices | Share |
|---|---|---|
| Laerdal Medical As | 13 | 21% |
| Mercury Enterprises, Inc. | 11 | 18% |
| Galemed Xiamen Co., Ltd. | 6 | 10% |
| Spiracle Technology | 6 | 10% |
| B.L.S. Systems Limited | 6 | 10% |
| Teleflex Incorporated | 6 | 10% |
| Ambu A/S | 5 | 8% |
| Enter Medical Corporation | 4 | 6% |
| Allied Medical, Llc | 4 | 6% |
| Parker-Hannifin Corporation | 1 | 2% |
Company = labeler of record on GUDID. 10 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 | 33 |
| BSJ | Mask, Gas, Anesthetic | 17 |
| BYG | MASK, OXYGEN | 11 |
| KGB | Mask, Oxygen, Non-Rebreathing | 6 |
| BYX | Tubing, Pressure And Accessories | 1 |
Use these as the dimensions to specify in a tender line.
62 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Resuscitator face mask, reusable", from 10 companies. The largest labeler is Laerdal Medical As with 21% of records.
BYG (Mask, Oxygen), BSJ (Mask, Gas, Anesthetic), BYG (MASK, OXYGEN), KGB (Mask, Oxygen, Non-Rebreathing)
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.