Consulting Wallah › Device Explorer › Equipment & monitoring › Patient monitoring system module, pulse oximetry
Device Explorer · FDA GUDID · GMDN 36554

Patient monitoring system module, pulse oximetry

A small unit dedicated to the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in blood using light detection methods (spectrophotometry) after light is emitted from a light-emitting diode (LED) situated in the connected probe. It is designed

US‑registered devices88in commercial distribution
Companies14labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription82%Rx‑only share
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Share of device records

Masimo Corporation3641%
Covidien Lp1416%
Draeger Medical Systems, Inc.1214%
Hypermed Imaging, Inc.67%
Ge Healthcare Finland Oy45%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.33%
Philips Medizin Systeme Böblingen Gmbh33%
Mipm Mammendorfer Institut Für Physik Und Medizin Gmbh22%

Top labelers

CompanyDevicesShare
Masimo Corporation3641%
Covidien Lp1416%
Draeger Medical Systems, Inc.1214%
Hypermed Imaging, Inc.67%
Ge Healthcare Finland Oy45%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.33%
Philips Medizin Systeme Böblingen Gmbh33%
Mipm Mammendorfer Institut Für Physik Und Medizin Gmbh22%
Philips Ds North America Llc22%
Respironics, Inc.22%
Shanghai Draeger Medical Instrument Co.,Ltd.11%
Iradimed Corp.11%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Kit, DPM4, DPM5, Nellcor SpO2SPO2 Module (Mindray/Package/ accessory)SPO2 Module (masimo/Package/ accessory/)Wireless Pulse Oximetry Sensor for Tesla DUOWireless Pulse Oximetry Sensor for TeslaDUOINFINITY MASIMO SET MOUNT KITINFINITY MASIMO SPO2 POD X8INFINITY MASIMO SPO2 POD USBINFINITY MCABLE-NELLCOR OXIMAXINFINITY NELLCOR SP02 POD X8INFINITY NELLCOR MOUNT KITSPO2 MASIMOSET POD SET USBSPO2 MASIMOSET POD SET X8SPO2 MASIMOSET POD SET KAPPASpO2 MasimoSET Pod Set - Kappa XLTSPO2 NELLCOR POD KIT DELTA

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

FDA product codes

CodeNameDevices
DQAOximeter73
MUDOximeter, Tissue Saturation8
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or5
MWIMonitor, Physiological, Patient (Without Arrhythmia Detectio4
OCHoximeter, infrared, sporting, aviation4
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR3

GMDN & GCC registration

  • GMDN code 36554 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 82% · OTC 5%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Meter) · 6Length (Centimeter) · 2

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

How many patient monitoring system module, pulse oximetry products are registered in the US?

88 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Patient monitoring system module, pulse oximetry", from 14 companies. The largest labeler is Masimo Corporation with 41% of records.

Which FDA product codes apply?

DQA (Oximeter), MUD (Oximeter, Tissue Saturation), MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or), MWI (Monitor, Physiological, Patient (Without Arrhythmia Detectio)

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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