Consulting Wallah › Device Explorer › Other devices › Room humidifier
Device Explorer · FDA GUDID · GMDN 16759

Room humidifier

A mains electricity (AC-powered) device intended to add moisture to ambient air, typically to prevent dryness of a patient's airways. This is a stationary device designed to be placed in one location in a room, typically in a hospital, institution, home, or of

US‑registered devices335in commercial distribution
Companies17labelers on GUDID
Single‑use8%of device records
Sterile0%labelled sterile
Prescription2%Rx‑only share
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Share of device records

Kaz Usa, Inc.15145%
Great Innovations, Llc8325%
Bear Down Consulting288%
Jarden Consumer Solutions216%
Silverfox Corporation Limited144%
Woonsocket Prescription Center, Incorporated93%
Wal-Mart Stores, Inc.51%
Besmed Health Business Corp.51%

Top labelers

CompanyDevicesShare
Kaz Usa, Inc.15145%
Great Innovations, Llc8325%
Bear Down Consulting288%
Jarden Consumer Solutions216%
Silverfox Corporation Limited144%
Woonsocket Prescription Center, Incorporated93%
Wal-Mart Stores, Inc.51%
Besmed Health Business Corp.51%
Kaz, Inc.41%
Rite Aid Corporation41%
Eng3 Corporation31%
Medsource International Llc31%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

silverfoxEquateEXINHI-FLOW BUBBLE HUMIDIFIER 400cc (6 psi),DISPOSABBUBBLE HUMIDIFIER 400ccBUBBLE HUMIDIFIER 400cc (6 psi), DISPOSABLEBUBBLE HUMIDIFIER 400cc (6 psi),DISPOSABLELARGE VOLUME NEBULIZER BOTTLE W/ABS LID 400cc, DPure EnrichmentNanoViClever Choice Ultrasonic HumidifierOxygen KitMedSource HumidifierMedSource Reusable HumidifierBREATH COMFORTvicks

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

FDA product codes

CodeNameDevices
KFZHumidifier, Non-Direct Patient Interface (Home-Use)322
CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)14

GMDN & GCC registration

  • GMDN code 16759 · non‑implantable
  • Single‑use 8% · sterile 0% · Rx‑only 2% · OTC 64%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Fluid Ounce) · 1Total Volume (Milliliter) · 1

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

No closely related category with 50+ devices.

How many room humidifier products are registered in the US?

335 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Room humidifier", from 17 companies. The largest labeler is Kaz Usa, Inc. with 45% of records.

Which FDA product codes apply?

KFZ (Humidifier, Non-Direct Patient Interface (Home-Use)), 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.

How do I get quotes?

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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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