Consulting Wallah › Device Explorer › Other devices › Pulmonary function analysis system, adult
Device Explorer · FDA GUDID · GMDN 35282

Pulmonary function analysis system, adult

A device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation

US‑registered devices309in commercial distribution
Companies18labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription41%Rx‑only share
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Share of device records

Jaeger Medical Gmbh12340%
Medical Graphics Corporation5618%
Airgas Usa Llc5217%
Thorasys Thoracic Medical Systems Inc237%
Vyaire Medical, Inc.93%
Ganshorn Medizin Electronic Gmbh83%
Fim Medical62%
Nspire Health, Inc.62%

Top labelers

CompanyDevicesShare
Jaeger Medical Gmbh12340%
Medical Graphics Corporation5618%
Airgas Usa Llc5217%
Thorasys Thoracic Medical Systems Inc237%
Vyaire Medical, Inc.93%
Ganshorn Medizin Electronic Gmbh83%
Fim Medical62%
Nspire Health, Inc.62%
Medi Soft Sa52%
Shape Medical Systems, Inc.52%
Innovision Aps41%
Vitalograph (Ireland) Limited31%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PowerCube+ Seriestremoflo C-100 Airwave Oscillometry System & Acctremoflo C2 Reference Test Load - 15cmH2O.s/L (2Calibrated Reference Load 15 cm H2O.s/L (2 Yearstf C2 Device - Ganshorn SpiroDef Mouthpiece Varitremoflo C2 Device - Yellow - VTG 28554tF C2 Sensor Module Labelled - Eco BVFtf C-100 Kit Vitalograph - Healthcare Edition (2tremoflo C-100 Airwave Oscillometry System & Acctremoflo C-100 Kit - Ganshorn SpiroDef MouthpiectF Calibrated Reference Load 15cmH2O (2 Years Edtremoflo C2 Airwave Oscillometry System and Accetremoflo C2 Reference Test Loadtremoflo C-100 Airwave Oscillometry - Support Artf C-100 Kit Vitalograph - Clinical Trial Editiotremoflo C2 Device - clearflo

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
BZCCalculator, Pulmonary Function Data179
BXKGas, Calibration (Specified Concentration)106
BZGSpirometer, Diagnostic51
BTYCalculator, Predicted Values, Pulmonary Function51
JAXPneumotachometer24
PNVImpedance Measuring Device Utilizing Oscillation Techniques23

GMDN & GCC registration

  • GMDN code 35282 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 41% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Pressure (Pound per Square Inch) · 50Total Volume (Liter) · 50

Use these as the dimensions to specify in a tender line.

How many pulmonary function analysis system, adult products are registered in the US?

309 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pulmonary function analysis system, adult", from 18 companies. The largest labeler is Jaeger Medical Gmbh with 40% of records.

Which FDA product codes apply?

BZC (Calculator, Pulmonary Function Data), BXK (Gas, Calibration (Specified Concentration)), BZG (Spirometer, Diagnostic), BTY (Calculator, Predicted Values, Pulmonary Function)

Is this the same as UAE/GCC registration?

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.

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