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Device Explorer · FDA GUDID · GMDN 35172

Aerosol face mask, non-rebreathing

A flexible, form-shaped device that is placed over the nose and mouth to deliver air, oxygen (O2), or a mixture of the two gases, with aerosolized particles, to a patient's airway. It includes two unidirectional valves, one that closes during inspiration to pr

US‑registered devices87in commercial distribution
Companies15labelers on GUDID
Single‑use74%of device records
Sterile0%labelled sterile
Prescription83%Rx‑only share
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Share of device records

Westmed, Inc.2428%
Salter Labs1922%
Bound Tree Medical, Llc78%
Dynarex Corporation67%
Allied Medical, Llc67%
Medline Industries, Inc.56%
Endure Industries45%
Sunmed, Llc45%

Top labelers

CompanyDevicesShare
Westmed, Inc.2428%
Salter Labs1922%
Bound Tree Medical, Llc78%
Dynarex Corporation67%
Allied Medical, Llc67%
Medline Industries, Inc.56%
Endure Industries45%
Sunmed, Llc45%
Medsource International Llc33%
Amsino International, Inc.33%
Mckesson Medical-Surgical Inc.22%
Tianjin Aoshang Outdoor Equipment Co.,Ltd11%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AOSHANGResponsive RespiratoryMedSource Aerosol MaskENDURE INDUSTRIESResp-O2 Aerosol Face Tent Mask, AdultResp-O2 Aerosol Elongated Masks, PediatricResp-O2 Aerosol Standard Mask, InfantResp-O2 Aerosol Standard Mask, PediatricResp-O2 Aerosol Elongated Masks, AdultResp-O2 Aerosol Standard Adult MaskCuraplexMaskInfant Oxygen MaskAerosol MasksElongated Aerosol MaskMask, Adult Oxygen W/7' KROT

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

FDA product codes

CodeNameDevices
BYGMask, Oxygen48
BYGMASK, OXYGEN24
KGBMask, Oxygen, Non-Rebreathing8
KGBMASK, OXYGEN, NON-REBREATHING8
BSJMask, Gas, Anesthetic2
CAFNebulizer (direct patient interface)2

GMDN & GCC registration

  • GMDN code 35172 · non‑implantable
  • Single‑use 74% · sterile 0% · Rx‑only 83% · OTC 2%
  • 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 aerosol face mask, non-rebreathing products are registered in the US?

87 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Aerosol face mask, non-rebreathing", from 15 companies. The largest labeler is Westmed, Inc. with 28% of records.

Which FDA product codes apply?

BYG (Mask, Oxygen), BYG (MASK, OXYGEN), KGB (Mask, Oxygen, Non-Rebreathing), KGB (MASK, OXYGEN, NON-REBREATHING)

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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