A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is made of non-conductive, soft, flexible polymers available in a range of sizes, and desig
| Company | Devices | Share |
|---|---|---|
| Hans Rudolph, Inc. | 56 | 13% |
| Canadian Hospital Specialties Limited | 50 | 12% |
| Flexicare Medical Limited | 45 | 11% |
| Teleflex Incorporated | 42 | 10% |
| Airlife | 28 | 7% |
| Intersurgical Incorporated | 26 | 6% |
| Well Lead Medical Co.,Ltd | 24 | 6% |
| Vyaire Medical, Inc. | 19 | 5% |
| Create Biotech Co., Ltd. | 15 | 4% |
| Ventlab, Llc | 10 | 2% |
| A-M Systems, Llc | 9 | 2% |
| Salter Labs | 9 | 2% |
Company = labeler of record on GUDID. 32 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 | 233 |
| BYG | MASK, OXYGEN | 106 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 40 |
| KGB | Mask, Oxygen, Non-Rebreathing | 33 |
| CBK | Ventilator, Continuous, Facility Use | 18 |
| CBN | APPARATUS, GAS-SCAVENGING | 16 |
Use these as the dimensions to specify in a tender line.
420 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Rebreathing oxygen face mask", from 32 companies. The largest labeler is Hans Rudolph, Inc. with 13% of records.
BYG (Mask, Oxygen), BYG (MASK, OXYGEN), CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), 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.