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Device Explorer · FDA GUDID · GMDN 47582

Pulse Co-oximeter probe, reusable

A photoelectric component of a pulse Co-oximeter that is applied externally to a body part (e.g., a fingertip for adults, the hand or foot for neonates), for the transcutaneous multiwave measurement of carboxy-haemoglobin saturation (SpCO) and typically severa

US‑registered devices358in commercial distribution
Companies6labelers on GUDID
Single‑use4%of device records
Sterile0%labelled sterile
Prescription75%Rx‑only share
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Share of device records

Apk Technology Co.,Ltd.28178%
Masimo Corporation4111%
Sentec Ag185%
Mipm Mammendorfer Institut Für Physik Und Medizin Gmbh164%
Rising Eagle Medical Llc10%
Medeia, Inc.10%

Top labelers

CompanyDevicesShare
Apk Technology Co.,Ltd.28178%
Masimo Corporation4111%
Sentec Ag185%
Mipm Mammendorfer Institut Für Physik Und Medizin Gmbh164%
Rising Eagle Medical Llc10%
Medeia, Inc.10%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

APKKontronNihon KohdenGE-NellcorHPSpO2 Adapter, small, 10/boxSpO2 Adapter, medium, 10/boxSpO2 Adapter, large, 10/boxSpO2 Adapter, small, 3/BoxSpO2 Adapter, medium, 3/BoxSpO2 Adapter, large, 3/BoxSpO2 Adapter - Basic (1x large / 1x medium / 1x SpO2 Adapter, largeSpO2 Adapter, mediumSpO2 Adapter, smallLNCS-II

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

FDA product codes

CodeNameDevices
DQAOximeter344
LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant N21
LKDMonitor, Carbon-Dioxide, Cutaneous21
KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthe21
DPZOximeter, Ear21
MWIMonitor, Physiological, Patient (Without Arrhythmia Detectio16

GMDN & GCC registration

  • GMDN code 47582 · non‑implantable
  • Single‑use 4% · sterile 0% · Rx‑only 75% · 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

Weight (Gram) · 1Total Volume (Milliliter) · 1

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

How many pulse co-oximeter probe, reusable products are registered in the US?

358 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pulse Co-oximeter probe, reusable", from 6 companies. The largest labeler is Apk Technology Co.,Ltd. with 78% of records.

Which FDA product codes apply?

DQA (Oximeter), LPP (Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant N), LKD (Monitor, Carbon-Dioxide, Cutaneous), KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthe)

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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