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Device Explorer · FDA GUDID · GMDN 12873

Stationary oxygen concentrator

A stationary mains electricity (AC-powered) device designed to concentrate oxygen (O2) from ambient air and deliver the concentrated O2, typically through an attached nasal cannula, to a patient requiring oxygen therapy. It processes the air through an interna

US‑registered devices232in commercial distribution
Companies22labelers on GUDID
Single‑use18%of device records
Sterile0%labelled sterile
Prescription77%Rx‑only share
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Share of device records

Nidek Medical Products, Inc.5323%
Caire Inc.4519%
Sunset Healthcare Solutions, Inc.4218%
Airsep Corporation3515%
Respironics, Inc.2310%
Devilbiss Healthcare Llc83%
Jiangsu Konsung Bio Medical Science And Technology Co., Ltd.31%
Dalton Medical Corporation31%

Top labelers

CompanyDevicesShare
Nidek Medical Products, Inc.5323%
Caire Inc.4519%
Sunset Healthcare Solutions, Inc.4218%
Airsep Corporation3515%
Respironics, Inc.2310%
Devilbiss Healthcare Llc83%
Jiangsu Konsung Bio Medical Science And Technology Co., Ltd.31%
Dalton Medical Corporation31%
Oxytek Medical Technology Co., Ltd.21%
Sysmed (China) Co.,Ltd21%
Shenyang Canta Medical Tech.Co.,Ltd21%
Invacare Corporation21%

Company = labeler of record on GUDID. 22 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OXTMOxygen ConcentratorOxygen concentratorkonsungInogenOwgels Oxygen ConcentratorDeVilbissOxyHomePlatinum® 10L Oxygen ConcentratorRepair PartsRepair PartRepair LabelREPAIR PARTREPAIR PARTSInvacare® Perfecto2V Oxygen ConcentratorInvacare® Platinum Oxygen Concentrator

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

FDA product codes

CodeNameDevices
CAWGenerator, Oxygen, Portable193
CAWGenerator, oxygen, portable46
OGLOxygen Administration Kit33
BYXTubing, Pressure And Accessories9
NFBConserver, oxygen1

GMDN & GCC registration

  • GMDN code 12873 · non‑implantable
  • Single‑use 18% · sterile 0% · Rx‑only 77% · 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

Height (Inch) · 3Width (Inch) · 3Length (Inch) · 3

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

How many stationary oxygen concentrator products are registered in the US?

232 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Stationary oxygen concentrator", from 22 companies. The largest labeler is Nidek Medical Products, Inc. with 23% of records.

Which FDA product codes apply?

CAW (Generator, Oxygen, Portable), CAW (Generator, oxygen, portable), OGL (Oxygen Administration Kit), BYX (Tubing, Pressure And Accessories)

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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