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Device Explorer · FDA GUDID · GMDN 44225

Oxygen/air breathing gas mixer, hospital

An independent mechanical device designed for accurate mixing of air and oxygen (O2) with O2 concentrations ranging from 21% to 100% (oxygen/air proportioner) that are appropriated for breathing in patients who need a concentration of O2 above the normal conce

US‑registered devices235in commercial distribution
Companies12labelers on GUDID
Single‑use4%of device records
Sterile0%labelled sterile
Prescription81%Rx‑only share
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Share of device records

Bio-Med Devices, Inc.9942%
Maxtec, Llc4519%
Sechrist Industries, Inc.4419%
Vyaire Medical, Inc.3113%
Gentec(Shanghai)Corporation42%
Precision Medical, Inc.31%
Inovytec Medical Solutions Ltd21%
Atom Medical Corporation21%

Top labelers

CompanyDevicesShare
Bio-Med Devices, Inc.9942%
Maxtec, Llc4519%
Sechrist Industries, Inc.4419%
Vyaire Medical, Inc.3113%
Gentec(Shanghai)Corporation42%
Precision Medical, Inc.31%
Inovytec Medical Solutions Ltd21%
Atom Medical Corporation21%
Tenacore Holdings, Inc.21%
Teleflex Incorporated10%
Boehringer Laboratories, Llc10%
Fisher & Paykel Healthcare Limited10%

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

Brand names on the register (sample)

Oxygen Enrichment KitOxygen MixerGENTEC®Blender Unit E typeBlender Unit P typeHUDSON RCISechrist Industries, Inc.TenacorePrecision Medical Inc.Precision Medical BlenderMaxBlend Lite, High Flow, 70LPMMaxBlend Lite, Low Flow, 30LPMMaxBlend Lite, Low Flow, 15LPMMaxBlend Lite, Low Flow, 3LPMMaxBlend2MicroMax

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

FDA product codes

CodeNameDevices
BZRMixer, Breathing Gases, Anesthesia Inhalation143
MODAccessory To Continuous Ventilator (Respirator)99
BZRMixer, breathing gases, anesthesia inhalation30
BYXTubing, Pressure And Accessories4
CBKVentilator, Continuous, Facility Use2
BYFMASK, OXYGEN, LOW CONCENTRATION, VENTURI2

GMDN & GCC registration

  • GMDN code 44225 · non‑implantable
  • Single‑use 4% · sterile 0% · Rx‑only 81% · 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

Depth (Inch) · 49Width (Inch) · 49Height (Inch) · 49Weight (Pound) · 48Width (Millimeter) · 2Height (Millimeter) · 2

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

No closely related category with 50+ devices.

How many oxygen/air breathing gas mixer, hospital products are registered in the US?

235 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Oxygen/air breathing gas mixer, hospital", from 12 companies. The largest labeler is Bio-Med Devices, Inc. with 42% of records.

Which FDA product codes apply?

BZR (Mixer, Breathing Gases, Anesthesia Inhalation), MOD (Accessory To Continuous Ventilator (Respirator)), BZR (Mixer, breathing gases, anesthesia inhalation), BYX (Tubing, Pressure And Accessories)

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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