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Device Explorer · FDA GUDID · GMDN 35173

Non-rebreathing oxygen face mask

A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent roo

US‑registered devices249in commercial distribution
Companies27labelers on GUDID
Single‑use76%of device records
Sterile0%labelled sterile
Prescription82%Rx‑only share
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Share of device records

Salter Labs6124%
Flexicare Medical Limited2510%
Teleflex Incorporated146%
Allied Medical, Llc146%
Asp Global, Llc135%
B.L.S. Systems Limited135%
Stryker Corporation125%
Dynarex Corporation125%

Top labelers

CompanyDevicesShare
Salter Labs6124%
Flexicare Medical Limited2510%
Teleflex Incorporated146%
Allied Medical, Llc146%
Asp Global, Llc135%
B.L.S. Systems Limited135%
Stryker Corporation125%
Dynarex Corporation125%
Bound Tree Medical, Llc125%
Medline Industries, Inc.125%
Medsource International Llc83%
Mckesson Medical-Surgical Inc.83%

Company = labeler of record on GUDID. 27 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Veoflo Nasal MaskVenticaire LiteAdult Non Rebreathing Mask with Ear Loops and 2.Adult Non Rebreathing Mask with Nose Clip Head SAdult Non Rebreathing Mask with Head Strap and 2Paediatric Non Rebreathing Mask with Head Strap INTERSURGICAL ECOLITE™, ADULT, HIGH CONCENTRATIOINTERSURGICAL ECOLITE, ADULT, HIGH CONCENTRATIORESPI-CHECK ADULT BREATHING INDICATOR HIGH CONCEHIGH CONCENTRATION NON-REBREATHING PAEDIATRIC OXADULT, HIGH CONCENTRATION OXYGEN MASK, WITH TUBECreate BiotechHUDSON RCIProcedural Oxygen MaskO2-Life™Mediox

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

FDA product codes

CodeNameDevices
KGBMask, Oxygen, Non-Rebreathing83
BYGMASK, OXYGEN64
KGBMASK, OXYGEN, NON-REBREATHING52
BYGMask, Oxygen33
BYFMASK, OXYGEN, LOW CONCENTRATION, VENTURI19
BSJMask, Gas, Anesthetic13

GMDN & GCC registration

  • GMDN code 35173 · non‑implantable
  • Single‑use 76% · sterile 0% · Rx‑only 82% · 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 (Feet) · 4

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

No closely related category with 50+ devices.

How many non-rebreathing oxygen face mask products are registered in the US?

249 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Non-rebreathing oxygen face mask", from 27 companies. The largest labeler is Salter Labs with 24% of records.

Which FDA product codes apply?

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

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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