Consulting Wallah › Device Explorer › Equipment & monitoring › Atomizer, non-ventilatory
Device Explorer · FDA GUDID · GMDN 10226

Atomizer, non-ventilatory

A non-powered, non-ventilatory device intended to provide liquid medication in an aerosolized airborne form for a patient to breathe. It is typically hand-operated. Unlike a nebulizer this devices lacks a baffle, therefore the particle size of the aerosol is n

US‑registered devices150in commercial distribution
Companies19labelers on GUDID
Single‑use85%of device records
Sterile1%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Ventlab, Llc5637%
Teleflex Incorporated3523%
Besmed Health Business Corp.2013%
Pulmodyne Inc75%
Engineered Medical Systems Inc64%
Br Surgical, Llc53%
Karl Storz Gmbh & Co. Kg43%
Anesthesia Associates, Inc.43%

Top labelers

CompanyDevicesShare
Ventlab, Llc5637%
Teleflex Incorporated3523%
Besmed Health Business Corp.2013%
Pulmodyne Inc75%
Engineered Medical Systems Inc64%
Br Surgical, Llc53%
Karl Storz Gmbh & Co. Kg43%
Anesthesia Associates, Inc.43%
Create Biotech Co., Ltd.21%
Slv Pharmaceuticals Llc21%
Health & Life Co., Ltd.11%
Peno Llc11%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LMA ATOMIZATIONCreate BiotechNorth American Health & WellnessNEBULIZER BOTTLE REUSABLE 6CC; OD:18mm,ONE PIECNEBULIZER BOTTLE REUSABLE 6CC; OD:18mmNEBULIZER SET 20CC W/T-PIECE, MOUTH PIECENEBULIZER SET 20CC W/T-PIECE, MOUTH PIECE, 6 INCJET NEBULIZER MASK , CHILD SET 20CC 7Ft OXYGEN TJET NEBULIZER MASK , ADULT SET 20CC 7Ft OXYGEN TMINI JET NEBULIZER SET 8CC W/7Ft OXYGEN TUBINGJET NEBULIZER MASK ,CHILD SET 8CC 7Ft OXYGEN TUBJET NEBULIZER MASK ,ADULT SET 8CC 7Ft OXYGEN TUBNEBULIZER BOTTLE DISPOSABLE 8CC; OD:18mmNEBULIZER PACIFIER W/ELBOW CONNECTOR & NEBULIZERMINI JET NEBULIZER SET 6CC W/7Ft OXYGEN TUBING (MINI JET NEBULIZER SET 6CC W/7Ft OXYGEN TUBING

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)79
CCQNEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)41
CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)21
CCTApplicator (Laryngo-Tracheal), Topical Anesthesia6
LRCINSTRUMENT, ENT MANUAL SURGICAL4
CAFNebulizer (direct patient interface)2

GMDN & GCC registration

  • GMDN code 10226 · non‑implantable
  • Single‑use 85% · sterile 1% · Rx‑only 93% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 22Length (Millimeter) · 6Length (Feet) · 3

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

No closely related category with 50+ devices.

How many atomizer, non-ventilatory products are registered in the US?

150 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Atomizer, non-ventilatory ", from 19 companies. The largest labeler is Ventlab, Llc with 37% of records.

Which FDA product codes apply?

CAF (Nebulizer (Direct Patient Interface)), CCQ (NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)), CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer)), CCT (Applicator (Laryngo-Tracheal), Topical Anesthesia)

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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