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Device Explorer · FDA GUDID · GMDN 35113

Non-heated respiratory humidifier, reusable

A non-powered device designed to prevent the drying of airway passages associated with the inhalation of oxygen (O2) by adding water vapour to the dry gas as it is passed through, or more seldom, over water. It typically consists of a graduated container (rese

US‑registered devices144in commercial distribution
Companies21labelers on GUDID
Single‑use31%of device records
Sterile6%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Salter Labs9062%
Sensimedical Llc64%
Westmed, Inc.64%
Allied Medical, Llc64%
Airlife43%
Eng3 Corporation32%
Sunset Healthcare Solutions, Inc.32%
Bound Tree Medical, Llc32%

Top labelers

CompanyDevicesShare
Salter Labs9062%
Sensimedical Llc64%
Westmed, Inc.64%
Allied Medical, Llc64%
Airlife43%
Eng3 Corporation32%
Sunset Healthcare Solutions, Inc.32%
Bound Tree Medical, Llc32%
Sunmed, Llc32%
Twin Med, Llc32%
Vyaire Medical, Inc.32%
Teleflex Incorporated21%

Company = labeler of record on GUDID. 21 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Water ChamberCreate BiotechBubble HumidifierHUDSON RCIResponsive RespiratoryNanoViBubble Humidifiers - 6psiResp-O2 Dry Bubble Humidifier, 6 PSI (Home Use),SENSIMEDICAL Sterile Water for Inhalation, USPNOVAPLUS Sterile Water for Inhalation, USPNOVAPLUS Sterile Water for InhalationCuraplexOxyGo Bubble HumidifierHumidifier AdaptorN/An/a

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

FDA product codes

CodeNameDevices
BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)110
KFZHumidifier, Non-Direct Patient Interface (Home-Use)23
BZEHEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR 23
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)20
OGGHumidifier Nebulizer Kit8
BZDVentilator, Non-Continuous (Respirator)1

GMDN & GCC registration

  • GMDN code 35113 · non‑implantable
  • Single‑use 31% · sterile 6% · Rx‑only 93% · OTC 3%
  • 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) · 1

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

How many non-heated respiratory humidifier, reusable products are registered in the US?

144 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Non-heated respiratory humidifier, reusable", from 21 companies. The largest labeler is Salter Labs with 62% of records.

Which FDA product codes apply?

BTT (HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)), KFZ (Humidifier, Non-Direct Patient Interface (Home-Use)), BZE (HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR ), BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))

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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