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Device Explorer · FDA GUDID · GMDN 57815

CPAP/BPAP nasal mask, reusable

A 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 medical oxygen

US‑registered devices1,489in commercial distribution
Companies21labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription69%Rx‑only share
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Share of device records

Resmed Pty Ltd43629%
Respironics, Inc.39827%
Sleepnet, Corp.1158%
Bmc Medical Co., Ltd.977%
Sunset Healthcare Solutions, Inc.926%
Fisher & Paykel Healthcare Limited644%
Circadiance, Llc594%
Innomed Technologies Inc523%

Top labelers

CompanyDevicesShare
Resmed Pty Ltd43629%
Respironics, Inc.39827%
Sleepnet, Corp.1158%
Bmc Medical Co., Ltd.977%
Sunset Healthcare Solutions, Inc.926%
Fisher & Paykel Healthcare Limited644%
Circadiance, Llc594%
Innomed Technologies Inc523%
Drive Devilbiss Healthcare403%
Suzhou Yuyue Medical Technology Co., Ltd.393%
Salter Labs332%
Wellell Inc.322%

Company = labeler of record on GUDID. 21 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Rio II Nasal MaskSiesta Nasal Mask(SML)Siesta Nasal Mask(L)Siesta Nasal Mask(M)Siesta Nasal Mask(S)Rio™ II Nasal Pillows InterfaceSiesta 2 Nasal MaskRio II Nasal Pillows InterfaceSiesta Nasal Mask (XL)Siesta Nasal Mask (L)Siesta Nasal Mask (M)Siesta Nasal Mask (S)Viva Nasal Mask Replacement Cushion-SmallViva Nasal Mask Replacement Cushion-MediumViva Nasal Mask Replacement Cushion-LargeRio II Nasal Pillows Interface Replacement Nasal

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)1,068
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)538
BYGMask, Oxygen40
BTKSTRAP, HEAD, GAS MASK4
ONZMechanical Ventilator3
MNSVentilator, Continuous, Non-Life-Supporting2

GMDN & GCC registration

  • GMDN code 57815 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 69% · OTC 4%
  • 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 cpap/bpap nasal mask, reusable products are registered in the US?

1,489 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "CPAP/BPAP nasal mask, reusable", from 21 companies. The largest labeler is Resmed Pty Ltd with 29% of records.

Which FDA product codes apply?

BZD (Ventilator, Non-Continuous (Respirator)), BZD (VENTILATOR, NON-CONTINUOUS (RESPIRATOR)), BYG (Mask, Oxygen), BTK (STRAP, HEAD, GAS MASK)

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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