Device Explorer · FDA GUDID · GMDN 60712

Home BPAP 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 bi-level positive airway pressure (BPAP) during spontaneous respiration for

US‑registered devices231in commercial distribution
Companies3labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Respironics, Inc.18078%
Resmed Pty Ltd2812%
Bmc Medical Co., Ltd.2310%

Top labelers

CompanyDevicesShare
Respironics, Inc.18078%
Resmed Pty Ltd2812%
Bmc Medical Co., Ltd.2310%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

G3 X BPAP SystemG3 X BPAP 25ALuna® G3 BPAP SystemLuna® G3 BPAP 25ARESmart® BPAP SystemWater chamberCellular ModuleAir FilterFilter CapPower Cord American StandardKnobAC/DC Power AdapterCarrying CasePM2.5 FilterWater ChamberAirCurve 11 ST-A

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)247
BZDVentilator, Non-Continuous (Respirator)34
MNSVentilator, Continuous, Non-Life-Supporting15
MDLImplant, Transmandibular3

GMDN & GCC registration

  • GMDN code 60712 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 96% · 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 home bpap unit products are registered in the US?

231 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Home BPAP unit", from 3 companies. The largest labeler is Respironics, Inc. with 78% of records.

Which FDA product codes apply?

BZD (VENTILATOR, NON-CONTINUOUS (RESPIRATOR)), BZD (Ventilator, Non-Continuous (Respirator)), MNS (Ventilator, Continuous, Non-Life-Supporting), MDL (Implant, Transmandibular)

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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