Consulting Wallah › Device Explorer › Syringes, needles & infusion › Spirometer/pulmonary function analyser syringe
Device Explorer · FDA GUDID · GMDN 17250

Spirometer/pulmonary function analyser syringe

A dedicated piston-in-barrel used for injecting small volumes of accurately measured amounts of gas into a spirometer, pulmonary function analyser, or other diagnostic pulmonary measuring/testing device for calibration or reference. It is typically a glass or

US‑registered devices212in commercial distribution
Companies5labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Hans Rudolph, Inc.18688%
A-M Systems, Llc209%
Vitalograph (Ireland) Limited42%
Medikro Oy10%
Vectracor Inc10%

Top labelers

CompanyDevicesShare
Hans Rudolph, Inc.18688%
A-M Systems, Llc209%
Vitalograph (Ireland) Limited42%
Medikro Oy10%
Vectracor Inc10%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

M9474, Medikro® Calibration Syringe, 3000 ml5550 1/2L SYRINGE5540 1L SYRINGE4900 7L SYRINGE5530 3L SYRINGE5520 7L SYRINGE5520 10ML SYRINGE5510 100ML SYRINGE3L Calibration Syringe5570 3L SYRINGE5510 7L SYRINGE5530 7L SYRINGE5570 7L SYRINGE5510 100ml SYRINGECR1914 SYRINGE5550 7L SYRINGE

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

FDA product codes

CodeNameDevices
BXWCalibrator, Volume, Gas211
BXWCALIBRATOR, VOLUME, GAS4

GMDN & GCC registration

  • GMDN code 17250 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 98% · 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

No structured size data on the register.

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

No closely related category with 50+ devices.

How many spirometer/pulmonary function analyser syringe products are registered in the US?

212 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Spirometer/pulmonary function analyser syringe", from 5 companies. The largest labeler is Hans Rudolph, Inc. with 88% of records.

Which FDA product codes apply?

BXW (Calibrator, Volume, Gas), BXW (CALIBRATOR, VOLUME, GAS)

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.

How do I get quotes?

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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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