Consulting Wallah › Device Explorer › Other devices › Breathing mouthpiece, single-use
Device Explorer · FDA GUDID · GMDN 44545

Breathing mouthpiece, single-use

A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that enables an appropriate gastig

US‑registered devices305in commercial distribution
Companies34labelers on GUDID
Single‑use95%of device records
Sterile0%labelled sterile
Prescription44%Rx‑only share
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Share of device records

Vitalograph (Ireland) Limited8026%
A-M Systems, Llc7023%
Vacumed3712%
S D I Diagnostics Inc258%
Jaeger Medical Gmbh155%
Alliance Tech Medical Inc93%
Medikro Oy83%
Intersurgical Incorporated72%

Top labelers

CompanyDevicesShare
Vitalograph (Ireland) Limited8026%
A-M Systems, Llc7023%
Vacumed3712%
S D I Diagnostics Inc258%
Jaeger Medical Gmbh155%
Alliance Tech Medical Inc93%
Medikro Oy83%
Intersurgical Incorporated72%
Clement Clarke International Limited72%
Besmed Health Business Corp.52%
Teleflex Incorporated41%
Henry Schein, Inc.41%

Company = labeler of record on GUDID. 34 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

N/AM9256-PCD, Disposable Flow Transducer, 100 pcsM9242-SP-90, SpiroSafe Disposable Flow TransduceM9256, SpiroSafe Disposable Flow Transducer703417 Disposable Flow Transducer QTY 4703418 Disposable Flow Transducer QTY 25703419 Disposable Flow Transducer QTY 100M9242-100, SpiroSafe Disposable Flow TransducerSteriBreath™ EcoNObreath®Maxineb DuoNIV ANGLED MOUTHPIECE WITH NOTCH 22M/15FNIV ANGLED MOUTHPIECE WITH NOTCH 15MMOUTHPIECE, 22FMOUTHPIECE, 22MClement Clarke International

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

FDA product codes

CodeNameDevices
BYPMouthpiece, Breathing170
BZGSPIROMETER, DIAGNOSTIC84
BZGSpirometer, Diagnostic61
BYPMOUTHPIECE, BREATHING48
CCJAnalyzer, Gas, Carbon-Monoxide, Gaseous-Phase2
MXASystem, Test, Breath Nitric Oxide1

GMDN & GCC registration

  • GMDN code 44545 · non‑implantable
  • Single‑use 95% · sterile 0% · Rx‑only 44% · 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

Length (Centimeter) · 1

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

How many breathing mouthpiece, single-use products are registered in the US?

305 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Breathing mouthpiece, single-use", from 34 companies. The largest labeler is Vitalograph (Ireland) Limited with 26% of records.

Which FDA product codes apply?

BYP (Mouthpiece, Breathing), BZG (SPIROMETER, DIAGNOSTIC), BZG (Spirometer, Diagnostic), BYP (MOUTHPIECE, BREATHING)

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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