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Device Explorer · FDA GUDID · GMDN 31266

Incentive spirometer

A hand-held, mechanical, breathing-muscle exerciser intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate ai

US‑registered devices106in commercial distribution
Companies22labelers on GUDID
Single‑use55%of device records
Sterile1%labelled sterile
Prescription86%Rx‑only share
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Share of device records

Icu Medical, Inc.2019%
Teleflex Incorporated1918%
D R Burton Healthcare, Llc98%
Clement Clarke International Limited88%
Anesthesia Associates, Inc.77%
Airlife77%
Medline Industries, Inc.77%
Besmed Health Business Corp.55%

Top labelers

CompanyDevicesShare
Icu Medical, Inc.2019%
Teleflex Incorporated1918%
D R Burton Healthcare, Llc98%
Clement Clarke International Limited88%
Anesthesia Associates, Inc.77%
Airlife77%
Medline Industries, Inc.77%
Besmed Health Business Corp.55%
Dynarex Corporation33%
Respironics Respiratory Drug Delivery (Uk) Ltd33%
Mckesson Medical-Surgical Inc.33%
Mcsc Medical, Llc22%

Company = labeler of record on GUDID. 22 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Hall BreatheIn-CheckMaxiPEPINCENTIVE SPIROMETERINCENTIVE SPIROMETER,5000MLINCENTIVE SPIROMETER,2500MLINCENTIVE SPIROMETER,600/900/1200MLHUDSON RCIBreather Med - cRMT Basic UDIThe BreatherPure Comfort Breath ExerciserPocketPEP with OxyJETPocketPEP OPEP DEVICE w/ T-PIECE ADAPTER & MOUTHPocketPEPPocketPEP AdvantageiPEP

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

FDA product codes

CodeNameDevices
BWFSPIROMETER, THERAPEUTIC (INCENTIVE)65
BWFSpirometer, Therapeutic (Incentive)37
BZHMeter, Peak Flow, Spirometry8
BZGSPIROMETER, DIAGNOSTIC8
NRHSystem, Breath Measurement1
BYPMouthpiece, Breathing1

GMDN & GCC registration

  • GMDN code 31266 · non‑implantable
  • Single‑use 55% · sterile 1% · Rx‑only 86% · OTC 2%
  • 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 incentive spirometer products are registered in the US?

106 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Incentive spirometer", from 22 companies. The largest labeler is Icu Medical, Inc. with 19% of records.

Which FDA product codes apply?

BWF (SPIROMETER, THERAPEUTIC (INCENTIVE)), BWF (Spirometer, Therapeutic (Incentive)), BZH (Meter, Peak Flow, Spirometry), BZG (SPIROMETER, DIAGNOSTIC)

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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