Device Explorer · FDA GUDID · GMDN 60711

Home CPAP unit

A portable, mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration,

US‑registered devices591in commercial distribution
Companies12labelers on GUDID
Single‑use4%of device records
Sterile0%labelled sterile
Prescription92%Rx‑only share
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Share of device records

Respironics, Inc.36762%
Resmed Pty Ltd6912%
Bmc Medical Co., Ltd.386%
Somnetics International, Inc.275%
Respironics Novametrix, Llc254%
Bleep, Llc234%
Wellell Inc.163%
Fisher & Paykel Healthcare Limited112%

Top labelers

CompanyDevicesShare
Respironics, Inc.36762%
Resmed Pty Ltd6912%
Bmc Medical Co., Ltd.386%
Somnetics International, Inc.275%
Respironics Novametrix, Llc254%
Bleep, Llc234%
Wellell Inc.163%
Fisher & Paykel Healthcare Limited112%
Sleepres, Llc92%
Sefam31%
Fresca Medical, Inc.20%
Resvent Medical Technology Co., Ltd.10%

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

Brand names on the register (sample)

RXiBreeze PAP SystemLuna® G3 CPAPLuna® G3 APAPBlank SD Card for Pap DevicesG3 X APAPDisplay ShellAC/DC Power AdapterFilter CapAuto CPAP SystemLuna® II CPAPLuna® II Auto CPAPLuna II QX Auto CPAPLuna II QX CPAPLuna II Auto CPAPLuna II CPAPRESmart® Auto CPAP System

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)524
BZDVentilator, Non-Continuous (Respirator)307
BYEAttachment, breathing, positive end expiratory pressure27
MNSVentilator, Continuous, Non-Life-Supporting13
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)4
CAWGenerator, oxygen, portable4

GMDN & GCC registration

  • GMDN code 60711 · non‑implantable
  • Single‑use 4% · sterile 0% · Rx‑only 92% · OTC 1%
  • 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) · 10Width (Inch) · 10Height (Inch) · 10Height (Millimeter) · 5Width (Millimeter) · 5Length (Millimeter) · 5

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

How many home cpap unit products are registered in the US?

591 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Home CPAP unit", from 12 companies. The largest labeler is Respironics, Inc. with 62% of records.

Which FDA product codes apply?

BZD (VENTILATOR, NON-CONTINUOUS (RESPIRATOR)), BZD (Ventilator, Non-Continuous (Respirator)), BYE (Attachment, breathing, positive end expiratory pressure), MNS (Ventilator, Continuous, Non-Life-Supporting)

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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