An assembly of devices designed to be interconnected to administer oxygen (O2) to a patient using various methods of oxygen administration (e.g., face mask, nasal canula) at different concentrations (e.g., via a gas mixer), duration of use, and flows. It will
| Company | Devices | Share |
|---|---|---|
| Pulmodyne Inc | 285 | 71% |
| Besmed Health Business Corp. | 44 | 11% |
| Vyaire Medical, Inc. | 20 | 5% |
| Anesthesia Associates, Inc. | 17 | 4% |
| Atom Medical Corporation | 9 | 2% |
| Cavagna Group Spa | 9 | 2% |
| Fisher & Paykel Healthcare Limited | 4 | 1% |
| Cavagna North America Inc | 2 | 1% |
| Nonin Medical, Inc. | 2 | 1% |
| A-M Systems, Llc | 2 | 1% |
| Instrumentation Industries, Incorporated | 2 | 1% |
| Engineered Medical Systems Inc | 1 | 0% |
Company = labeler of record on GUDID. 14 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 |
|---|---|---|
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 286 |
| BYG | Mask, Oxygen | 47 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 25 |
| BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 20 |
| CAN | Regulator, Pressure, Gas Cylinder | 11 |
| BTL | Ventilator, emergency, powered (resuscitator) | 3 |
Use these as the dimensions to specify in a tender line.
399 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Respiratory oxygen therapy system", from 14 companies. The largest labeler is Pulmodyne Inc with 71% of records.
BYE (Attachment, Breathing, Positive End Expiratory Pressure), BYG (Mask, Oxygen), BTL (Ventilator, Emergency, Powered (Resuscitator)), BZD (VENTILATOR, NON-CONTINUOUS (RESPIRATOR))
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.