A non-sterile, portable, screening device intended to be used during pulmonary function testing to remove and retain microdroplets from patient breath to reduce contamination of the parent device; it is also intended to function as a mouthpiece to facilitate a
| Company | Devices | Share |
|---|---|---|
| Polytechnic Resources Inc | 164 | 34% |
| A-M Systems, Llc | 86 | 18% |
| S D I Diagnostics Inc | 80 | 16% |
| Tri-Anim Health Services, Inc. | 36 | 7% |
| Medical Graphics Corporation | 29 | 6% |
| Westmed, Inc. | 24 | 5% |
| Nspire Health, Inc. | 12 | 2% |
| Sunmed, Llc | 12 | 2% |
| Ndd Medizintechnik Ag | 11 | 2% |
| Medline Industries, Inc. | 10 | 2% |
| Intersurgical Incorporated | 5 | 1% |
| Fim Medical | 4 | 1% |
Company = labeler of record on GUDID. 18 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 |
|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | 273 |
| BZG | Spirometer, Diagnostic | 215 |
| BZG | SPIROMETER, DIAGNOSTIC | 45 |
| BYP | Mouthpiece, Breathing | 16 |
| MXA | System,Test,Breath Nitric Oxide | 2 |
| BYP | MOUTHPIECE, BREATHING | 2 |
Use these as the dimensions to specify in a tender line.
486 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pulmonary function testing filter/mouthpiece", from 18 companies. The largest labeler is Polytechnic Resources Inc with 34% of records.
CAH (Filter, Bacterial, Breathing-Circuit), BZG (Spirometer, Diagnostic), BZG (SPIROMETER, DIAGNOSTIC), BYP (Mouthpiece, Breathing)
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.