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Device Explorer · FDA GUDID · GMDN 57828

Professional high-flow respiratory unit, humidifying, manual

An electrically-powered device designed to deliver high-flow (exceeding peak inspiratory flow) heated and humidified ambient air or air/oxygen, at a manually set oxygen concentration (FiO2), to a spontaneously breathing patient. It is intended for use by a hea

US‑registered devices132in commercial distribution
Companies4labelers on GUDID
Single‑use77%of device records
Sterile0%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Vapotherm, Inc.12393%
Fisher & Paykel Healthcare Limited54%
Tni Medical Ag32%
Telesair, Inc.11%

Top labelers

CompanyDevicesShare
Vapotherm, Inc.12393%
Fisher & Paykel Healthcare Limited54%
Tni Medical Ag32%
Telesair, Inc.11%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

softFlowBonhawa Respiratory HumidifierVapothermVapotherm Inc.Fisher & Paykel Healthcare

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)131
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device3

GMDN & GCC registration

  • GMDN code 57828 · non‑implantable
  • Single‑use 77% · sterile 0% · Rx‑only 99% · OTC 0%
  • 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 professional high-flow respiratory unit, humidifying, manual products are registered in the US?

132 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Professional high-flow respiratory unit, humidifying, manual", from 4 companies. The largest labeler is Vapotherm, Inc. with 93% of records.

Which FDA product codes apply?

BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), QAV (High Flow/High Velocity Humidified Oxygen Delivery Device)

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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