Consulting Wallah › Device Explorer › Other devices › Pulse Co-oximeter
Device Explorer · FDA GUDID · GMDN 46201

Pulse Co-oximeter

A portable, battery-powered, electronic device designed to detect hypoxia (oxygen deficiency at the tissue level) via the transcutaneous multiwave measurement and display of carboxy-haemoglobin saturation (SpCO) and typically other related parameters such as h

US‑registered devices80in commercial distribution
Companies3labelers on GUDID
Single‑use4%of device records
Sterile0%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Masimo Corporation7695%
Drive Devilbiss Healthcare34%
Shenzhen Bsx Technology Electronics Co., Ltd.11%

Top labelers

CompanyDevicesShare
Masimo Corporation7695%
Drive Devilbiss Healthcare34%
Shenzhen Bsx Technology Electronics Co., Ltd.11%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BSXMEDRadius PPGMasimo SensorRad-97MasimoLNCSRadius-PPGRadius-7Rad-67ProntoRad-87™ Horizontal signal extraction pulse co-oxPronto™ Pulse CO-Oximeter™Kit, Pronto Pulse CO-Oximeter DCIP SC-400Kit, Pronto Pulse CO-Oximeter DCIP SC-200Kit, Pronto Pulse CO-Oximeter DCI SC-400Kit, Pronto Pulse CO-Oximeter DCI SC-200, DCIP S

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

FDA product codes

CodeNameDevices
DQAOximeter68
MWIMonitor, physiological, patient (without arrhythmia detectio7
OCHoximeter, infrared, sporting, aviation4
MWIMonitor, Physiological, Patient (Without Arrhythmia Detectio3

GMDN & GCC registration

  • GMDN code 46201 · non‑implantable
  • Single‑use 4% · sterile 0% · Rx‑only 96% · OTC 1%
  • 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 pulse co-oximeter products are registered in the US?

80 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pulse Co-oximeter", from 3 companies. The largest labeler is Masimo Corporation with 95% of records.

Which FDA product codes apply?

DQA (Oximeter), MWI (Monitor, physiological, patient (without arrhythmia detectio), OCH (oximeter, infrared, sporting, aviation), 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.

How do I get quotes?

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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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