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Device Explorer · FDA GUDID · GMDN 12050

Heated respiratory humidifier

A mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilatio

US‑registered devices377in commercial distribution
Companies25labelers on GUDID
Single‑use12%of device records
Sterile2%labelled sterile
Prescription84%Rx‑only share
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Share of device records

Respironics, Inc.15441%
Teleflex Incorporated5916%
Resmed Pty Ltd318%
Fisher & Paykel Healthcare Limited287%
Flexicare Medical Limited216%
International Biomedical, Ltd.144%
Pegasus Research Corporation144%
Bmc Medical Co., Ltd.103%

Top labelers

CompanyDevicesShare
Respironics, Inc.15441%
Teleflex Incorporated5916%
Resmed Pty Ltd318%
Fisher & Paykel Healthcare Limited287%
Flexicare Medical Limited216%
International Biomedical, Ltd.144%
Pegasus Research Corporation144%
Bmc Medical Co., Ltd.103%
Perma Pure Llc62%
Airlife62%
Medline Industries, Inc.62%
Sunset Healthcare Solutions, Inc.41%

Company = labeler of record on GUDID. 25 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Vivo 1/2, Vivo 3RESmart® BPAP System with Integrated Heated HumiLuna® CPAP System with Integrated Heated HumidifLuna®RESmart® Auto CPAP System with Integrated HeatedRESmart® CPAP System with Integrated Heated HumiRESmart® Integrated Heated Humidifier for BPAP 2RESmart® Integrated Heated Humidifier for Auto CRESmart® Integrated Heated Humidifier for CPAPFL9000FL-10000UWater Bag PoleWater Bag Pole Mounting BracketFL-9000 RESPIRATORY HUMIDIFIER USASing Heated Wire Humidifier AdapterDual Heated Wire Humidifier Adapter

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

FDA product codes

CodeNameDevices
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)135
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)114
BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)95
BZDVentilator, Non-Continuous (Respirator)39
MNTVentilator, continuous, minimal ventilatory support, facilit22
MNSVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING20

GMDN & GCC registration

  • GMDN code 12050 · non‑implantable
  • Single‑use 12% · sterile 2% · Rx‑only 84% · 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

Height (Inch) · 17Outer Diameter (Inch) · 12Weight (Pound) · 8Length (Inch) · 7Width (Inch) · 3Circumference (Inch) · 2

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

How many heated respiratory humidifier products are registered in the US?

377 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Heated respiratory humidifier", from 25 companies. The largest labeler is Respironics, Inc. with 41% of records.

Which FDA product codes apply?

BZD (VENTILATOR, NON-CONTINUOUS (RESPIRATOR)), BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), BTT (HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)), BZD (Ventilator, Non-Continuous (Respirator))

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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