A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid hollow device with a shape and structure that enables an appropriate gastight seal
| Company | Devices | Share |
|---|---|---|
| Apnicure, Inc. | 42 | 38% |
| A-M Systems, Llc | 23 | 21% |
| Jaeger Medical Gmbh | 21 | 19% |
| Shinrin-Yoku Traders Llc | 9 | 8% |
| Monaghan Medical Corporation | 4 | 4% |
| S D I Diagnostics Inc | 4 | 4% |
| Allied Medical, Llc | 3 | 3% |
| Clement Clarke International Limited | 1 | 1% |
| Dynarex Corporation | 1 | 1% |
| Icu Medical, Inc. | 1 | 1% |
| Medline Industries, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 11 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 |
|---|---|---|
| BYP | Mouthpiece, Breathing | 59 |
| OZR | Intraoral Pressure Gradient Device | 42 |
| LRK | Device, Anti-Snoring | 9 |
| BZG | Spirometer, Diagnostic | 8 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 4 |
| CAF | Nebulizer (Direct Patient Interface) | 3 |
Use these as the dimensions to specify in a tender line.
110 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Breathing mouthpiece, reusable", from 11 companies. The largest labeler is Apnicure, Inc. with 38% of records.
BYP (Mouthpiece, Breathing), OZR (Intraoral Pressure Gradient Device), LRK (Device, Anti-Snoring), BZG (Spirometer, Diagnostic)
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.