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Device Explorer · FDA GUDID · GMDN 37591

CPAP/BPAP nasal mask, single-use

A non-sterile, flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or me

US‑registered devices340in commercial distribution
Companies17labelers on GUDID
Single‑use74%of device records
Sterile0%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Mercury Enterprises, Inc.7422%
Airlife4212%
Pulmodyne Inc4112%
Respironics, Inc.4112%
Bound Tree Medical, Llc206%
Sefam165%
Airon Corporation165%
Sleepnet, Corp.165%

Top labelers

CompanyDevicesShare
Mercury Enterprises, Inc.7422%
Airlife4212%
Pulmodyne Inc4112%
Respironics, Inc.4112%
Bound Tree Medical, Llc206%
Sefam165%
Airon Corporation165%
Sleepnet, Corp.165%
Innomed Technologies Inc144%
Salter Labs124%
Fisher & Paykel Healthcare Limited124%
Fresca Medical, Inc.113%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BreezeminiFlowMedioxPro-FitBiTrac VentedBiTracWhisper SoftBiTrac HCBitrac HCBiTrac SE SelectNasal-Aire IISylent NECuraplexNovaplus Hospital Nasal Non Vented Mask, m/lNovaplus Hospital Nasal Non Vented Mask, s/mNovaplus Hospital Nasal Vented Mask, m/l

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)139
BYEAttachment, Breathing, Positive End Expiratory Pressure90
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)73
CBKVentilator, Continuous, Facility Use25
BYEAttachment, breathing, positive end expiratory pressure18
BYGMASK, OXYGEN13

GMDN & GCC registration

  • GMDN code 37591 · non‑implantable
  • Single‑use 74% · sterile 0% · Rx‑only 93% · 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

Length (Inch) · 18Height (Inch) · 16Width (Inch) · 16Weight (Pound) · 16

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

How many cpap/bpap nasal mask, single-use products are registered in the US?

340 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "CPAP/BPAP nasal mask, single-use", from 17 companies. The largest labeler is Mercury Enterprises, Inc. with 22% of records.

Which FDA product codes apply?

BZD (Ventilator, Non-Continuous (Respirator)), BYE (Attachment, Breathing, Positive End Expiratory Pressure), BZD (VENTILATOR, NON-CONTINUOUS (RESPIRATOR)), CBK (Ventilator, Continuous, Facility Use)

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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