Consulting Wallah › Device Explorer › Equipment & monitoring › Respiratory oxygen therapy physiologic monitor/gas
Device Explorer · FDA GUDID · GMDN 63057

Respiratory oxygen therapy physiologic monitor/gas regulator

An electrically-powered unit designed to be connected to a pulse oximeter sensor and used during the administration of oxygen (O2) to a spontaneously breathing patient, for: 1) continuous monitoring of physiologic parameters, especially haemoglobin oxygen satu

US‑registered devices61in commercial distribution
Companies1labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription95%Rx‑only share
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Share of device records

Vapotherm, Inc.61100%

Top labelers

CompanyDevicesShare
Vapotherm, Inc.61100%

Company = labeler of record on GUDID. 1 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Vapotherm

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

FDA product codes

CodeNameDevices
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device61
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)61

GMDN & GCC registration

  • GMDN code 63057 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 95% · 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 respiratory oxygen therapy physiologic monitor/gas regulator products are registered in the US?

61 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Respiratory oxygen therapy physiologic monitor/gas regulator", from 1 companies. The largest labeler is Vapotherm, Inc. with 100% of records.

Which FDA product codes apply?

QAV (High Flow/High Velocity Humidified Oxygen Delivery Device), 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.

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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