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Device Explorer · FDA GUDID · GMDN 35457

Therapeutic agent nebulizer, benchtop

An assembly of devices intended to be used in the home and clinical to aerosolize medication/fluids, by non-heat-dependent means (i.e., not a vaporizer), for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive p

US‑registered devices982in commercial distribution
Companies53labelers on GUDID
Single‑use34%of device records
Sterile0%labelled sterile
Prescription79%Rx‑only share
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Share of device records

Respironics Respiratory Drug Delivery (Uk) Ltd22823%
Salter Labs16717%
Aerogen Limited778%
Teleflex Incorporated707%
Airlife626%
Drive Devilbiss Healthcare596%
Sunset Healthcare Solutions, Inc.566%
Vyaire Medical, Inc.434%

Top labelers

CompanyDevicesShare
Respironics Respiratory Drug Delivery (Uk) Ltd22823%
Salter Labs16717%
Aerogen Limited778%
Teleflex Incorporated707%
Airlife626%
Drive Devilbiss Healthcare596%
Sunset Healthcare Solutions, Inc.566%
Vyaire Medical, Inc.434%
Medline Industries, Inc.232%
Dynarex Corporation202%
Flexicare Medical Limited152%
Allied Medical, Llc152%

Company = labeler of record on GUDID. 53 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Nebulizer(direct patient interface)JermeiYirdocAleshonFOFOCompressor NebulizerRhythm HealthcareBalnoreLuminviaNebulizerCONTECPortable Mesh NebulizerAerogen® Solo; Aerogen UltraAerogen® Solo Nebulizer SystemAerogen® USB Controller SystemAerogen® Solo Nebulization System

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

FDA product codes

CodeNameDevices
CAFNEBULIZER (DIRECT PATIENT INTERFACE)537
CAFNebulizer (Direct Patient Interface)396
BTICompressor, air, portable307
CCQNEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)106
CAFNebulizer (direct patient interface)82
BTICompressor, Air, Portable27

GMDN & GCC registration

  • GMDN code 35457 · non‑implantable
  • Single‑use 34% · sterile 0% · Rx‑only 79% · OTC 8%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Height (Inch) · 4Width (Inch) · 4Length (Inch) · 4Length (Feet) · 3

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

How many therapeutic agent nebulizer, benchtop products are registered in the US?

982 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Therapeutic agent nebulizer, benchtop", from 53 companies. The largest labeler is Respironics Respiratory Drug Delivery (Uk) Ltd with 23% of records.

Which FDA product codes apply?

CAF (NEBULIZER (DIRECT PATIENT INTERFACE)), CAF (Nebulizer (Direct Patient Interface)), BTI (Compressor, air, portable), CCQ (NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER))

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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