Consulting Wallah › Device Explorer › Other devices › Pulse Co-oximeter probe, single-use
Device Explorer · FDA GUDID · GMDN 47581

Pulse Co-oximeter probe, single-use

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 devices318in commercial distribution
Companies4labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription15%Rx‑only share
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Share of device records

Apk Technology Co.,Ltd.28590%
Masimo Corporation309%
Rising Eagle Medical Llc21%
Authentic Medical10%

Top labelers

CompanyDevicesShare
Apk Technology Co.,Ltd.28590%
Masimo Corporation309%
Rising Eagle Medical Llc21%
Authentic Medical10%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

APKRD rainbowSureLeadRadius-PPGRD rainbow SET-2MasimoSET® Rainbow Ped/Inf Sensor Sample PackMasimoSET® Rainbow Adult Sensor Sample Packrainbow ReSposable, R2-25a, Adult Pulse CO-Oximerainbow ReSposable R2-20a Pediatric/Slender DigiRadius PPGrainbow® R1 20L SpHb® SpO2 SpMet® Infant CO-OximR1 20 Pediatric/Slender digit Pulse Co-OximeterR1 25 SpHb® SpO2, SpMet® Adult Pulse Co-Oximeterrainbow R1 25L SpHb SpO2 SpMet Adult/Neonatal Purainbow R25-L SpCO SpO2 SpMet® Adult/Neonatal PuMasimoSET® rainbow R25 SpCO SpO2 SpMet® Adult Pu

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

FDA product codes

CodeNameDevices
DQAOximeter316
QVTMonitor For Opioid Induced Impairment Of Oxygenation2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detectio2

GMDN & GCC registration

  • GMDN code 47581 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 15% · 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

No structured size data on the register.

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

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

318 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pulse Co-oximeter probe, single-use", from 4 companies. The largest labeler is Apk Technology Co.,Ltd. with 90% of records.

Which FDA product codes apply?

DQA (Oximeter), QVT (Monitor For Opioid Induced Impairment Of Oxygenation), 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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