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Device Explorer · FDA GUDID · GMDN 12719

Ultrasonic nebulizing system

An assembly of devices designed to generate aerosolized medication/fluids (finely dispersed airborne droplets) for inhalation by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It typically cons

US‑registered devices133in commercial distribution
Companies15labelers on GUDID
Single‑use6%of device records
Sterile0%labelled sterile
Prescription84%Rx‑only share
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Share of device records

Respironics Respiratory Drug Delivery (Uk) Ltd7758%
Pari Respiratory Equipment, Inc.1914%
Veridian Healthcare Llc75%
Honsun (Nantong) Co.,Ltd65%
Vortran Medical Technology 1, Inc65%
Health & Life Co., Ltd.32%
Microvapor Devices, Llc32%
Amtrion Gmbh22%

Top labelers

CompanyDevicesShare
Respironics Respiratory Drug Delivery (Uk) Ltd7758%
Pari Respiratory Equipment, Inc.1914%
Veridian Healthcare Llc75%
Honsun (Nantong) Co.,Ltd65%
Vortran Medical Technology 1, Inc65%
Health & Life Co., Ltd.32%
Microvapor Devices, Llc32%
Amtrion Gmbh22%
Dongguan Polygreen Technology Co., Ltd.22%
Airehealth Llc22%
Medline Industries, Inc.22%
Convexity Scientific Llc11%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HANGSUNTake a breathALERTCAREeMistClinical GuardUSV 2010PolygreenFLYpAura MedicalAireHealth NebulizerPocket NebBeurerVeridianVERIDIANCaring MillLamira

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)76
CAFNebulizer (Direct Patient Interface)53
CAFNebulizer (direct patient interface)6
NHJDevice, Positive Pressure Breathing, Intermittent6
BTMVentilator, emergency, manual (resuscitator)1
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE1

GMDN & GCC registration

  • GMDN code 12719 · non‑implantable
  • Single‑use 6% · sterile 0% · Rx‑only 84% · OTC 5%
  • 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.

How many ultrasonic nebulizing system products are registered in the US?

133 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ultrasonic nebulizing system", from 15 companies. The largest labeler is Respironics Respiratory Drug Delivery (Uk) Ltd with 58% of records.

Which FDA product codes apply?

CAF (NEBULIZER (DIRECT PATIENT INTERFACE)), CAF (Nebulizer (Direct Patient Interface)), CAF (Nebulizer (direct patient interface)), NHJ (Device, Positive Pressure Breathing, Intermittent)

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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