Consulting Wallah › Device Explorer › Other devices › Heat/moisture exchanger, single-use
Device Explorer · FDA GUDID · GMDN 35530

Heat/moisture exchanger, single-use

"A one-piece, canister-like device that connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube], to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the pa

US‑registered devices371in commercial distribution
Companies44labelers on GUDID
Single‑use98%of device records
Sterile8%labelled sterile
Prescription69%Rx‑only share
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Share of device records

Teleflex Incorporated8122%
Gvs Technology (Suzhou) Co., Ltd.308%
Freudenberg Medical, Llc226%
Pharma Systems Ps Ab226%
Vr Medical Technology Co., Ltd.164%
Airlife164%
Flexicare Medical Limited144%
Intersurgical Incorporated144%

Top labelers

CompanyDevicesShare
Teleflex Incorporated8122%
Gvs Technology (Suzhou) Co., Ltd.308%
Freudenberg Medical, Llc226%
Pharma Systems Ps Ab226%
Vr Medical Technology Co., Ltd.164%
Airlife164%
Flexicare Medical Limited144%
Intersurgical Incorporated144%
Pepper Medical Inc.134%
Sunset Healthcare Solutions, Inc.134%
Medline Industries, Inc.103%
Vyaire Medical, Inc.92%

Company = labeler of record on GUDID. 44 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAClimavent XS Angled HME Extra SmallClimatrach Tracheostomy HME + Oxygen Port + SafeClimatrach Tracheostomy HME with Safety ValveClimatrach Tracheostomy HME with Oxygen PortClimatrach Tracheostomy HME StandardClimavent XS HME Extra SmallClimavent Child Angled HMEClimavent Child Straight HMEClimavent HMEClimavent S Angled HME SmallClimavent S HME SmallThermoTrach Tracheostomy Low Resistance HME withThermoTrach Tracheostomy HME with Vent and SwiveThermoTrach Tracheostomy HME with Vent Swivel OxINTER THERM T HME -STERILE

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

FDA product codes

CodeNameDevices
BYDCondenser, Heat And Moisture (Artificial Nose)190
BYDCONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)139
CAHFilter, Bacterial, Breathing-Circuit32
OGGHumidifier nebulizer kit15
CAHFilter, bacterial, breathing-circuit15
JOHTube Tracheostomy And Tube Cuff7

GMDN & GCC registration

  • GMDN code 35530 · non‑implantable
  • Single‑use 98% · sterile 8% · Rx‑only 69% · 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

Length (Centimeter) · 22Total Volume (Milliliter) · 5Weight (Gram) · 5Length (Feet) · 4Outer Diameter (Millimeter) · 1

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

How many heat/moisture exchanger, single-use products are registered in the US?

371 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Heat/moisture exchanger, single-use", from 44 companies. The largest labeler is Teleflex Incorporated with 22% of records.

Which FDA product codes apply?

BYD (Condenser, Heat And Moisture (Artificial Nose)), BYD (CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)), CAH (Filter, Bacterial, Breathing-Circuit), OGG (Humidifier nebulizer kit)

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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