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Device Explorer · FDA GUDID · GMDN 13538

Respiratory oxygen sensor

A device designed to detect the presence and determine the concentration of oxygen (O2) by paramagnetic, electrochemical, or other technique. The device is typically used as a component of an oxygen monitor or a patient monitoring device/system that determines

US‑registered devices462in commercial distribution
Companies18labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription53%Rx‑only share
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Share of device records

Maxtec, Llc9521%
It Dr. Gambert Gmbh9019%
Analytical Industries Inc.6514%
Honeywell Healthcare Solutions Gmbh6213%
S. L. P. Scientific Laboratory Products Ltd388%
Vapotherm, Inc.388%
Mercury Enterprises, Inc.266%
Sensoronics Incorporated153%

Top labelers

CompanyDevicesShare
Maxtec, Llc9521%
It Dr. Gambert Gmbh9019%
Analytical Industries Inc.6514%
Honeywell Healthcare Solutions Gmbh6213%
S. L. P. Scientific Laboratory Products Ltd388%
Vapotherm, Inc.388%
Mercury Enterprises, Inc.266%
Sensoronics Incorporated153%
Teledyne Analytical Instrs143%
City Technology Limited82%
Avante31%
Drive Devilbiss Healthcare20%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Vivo 45 LSOxSat100OxSAT100SleepsenseSleepSenseO2-SensorOxygen SensorAnalytical Industries Inc.Artema Anesthetic Oxygen (O2) SensorPrecision Medical Inc.MAX-13 SENSOR, PRECISION MEDICAL 504877MAX-16MAX-11MAX-250 EASI CO2-O2MAX-108A

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

FDA product codes

CodeNameDevices
CCLAnalyzer, Gas, Oxygen, Gaseous-Phase312
CCLANALYZER, GAS, OXYGEN, GASEOUS-PHASE68
DQAOximeter62
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device11
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)3
MNRVentilatory Effort Recorder2

GMDN & GCC registration

  • GMDN code 13538 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 53% · 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

Width (Millimeter) · 37Height (Millimeter) · 37Length (Millimeter) · 36Height (Centimeter) · 4Weight (Gram) · 2Outer Diameter (Millimeter) · 1

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

How many respiratory oxygen sensor products are registered in the US?

462 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Respiratory oxygen sensor", from 18 companies. The largest labeler is Maxtec, Llc with 21% of records.

Which FDA product codes apply?

CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), CCL (ANALYZER, GAS, OXYGEN, GASEOUS-PHASE), DQA (Oximeter), QAV (High Flow/High Velocity Humidified Oxygen Delivery Device)

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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