A non-sterile, 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 (
| Company | Devices | Share |
|---|---|---|
| Foremount Enterprise Co., Ltd. | 52 | 39% |
| Medline Industries, Inc. | 45 | 34% |
| B.L.S. Systems Limited | 7 | 5% |
| Kentron Healthcare, Inc. | 6 | 5% |
| Fisher & Paykel Healthcare Limited | 6 | 5% |
| Laerdal Medical As | 5 | 4% |
| Hopkins Uniform Company | 5 | 4% |
| Bound Tree Medical, Llc | 4 | 3% |
| Allied Medical, Llc | 2 | 2% |
| Enter Medical Corporation | 1 | 1% |
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 |
|---|---|---|
| CBP | Valve, Non-Rebreathing | 52 |
| BTM | Ventilator, emergency, manual (resuscitator) | 36 |
| BSJ | Mask, Gas, Anesthetic | 14 |
| BYG | Mask, Oxygen | 13 |
| KGB | MASK, OXYGEN, NON-REBREATHING | 8 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 7 |
Use these as the dimensions to specify in a tender line.
133 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Resuscitator face mask, single-use", from 10 companies. The largest labeler is Foremount Enterprise Co., Ltd. with 39% of records.
CBP (Valve, Non-Rebreathing), BTM (Ventilator, emergency, manual (resuscitator)), BSJ (Mask, Gas, Anesthetic), 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.