A collection of non-sterile devices intended to be used in conjunction with pulmonary function analysis equipment to perform a pulmonary function test. It may include a breathing mouthpiece, filter (intended to reduce contamination of parent device), and a nos
| Company | Devices | Share |
|---|---|---|
| A-M Systems, Llc | 110 | 43% |
| S D I Diagnostics Inc | 37 | 15% |
| Polytechnic Resources Inc | 26 | 10% |
| Tri-Anim Health Services, Inc. | 20 | 8% |
| Medical Graphics Corporation | 18 | 7% |
| Alliance Tech Medical Inc | 16 | 6% |
| Intersurgical Incorporated | 15 | 6% |
| Nspire Health, Inc. | 8 | 3% |
| Shape Medical Systems, Inc. | 3 | 1% |
| Engineered Medical Systems Inc | 1 | 0% |
| Aktina Corp. | 1 | 0% |
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 |
|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | 204 |
| BZG | Spirometer, Diagnostic | 60 |
| BZG | SPIROMETER, DIAGNOSTIC | 20 |
| BYP | Mouthpiece, Breathing | 9 |
| BXJ | Clip, Nose | 6 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 3 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
255 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pulmonary function testing kit", from 11 companies. The largest labeler is A-M Systems, Llc with 43% 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.