Consulting Wallah › Device Explorer › Other devices › Pulse oximeter probe, reprocessed
Device Explorer · FDA GUDID · GMDN 36087

Pulse oximeter probe, reprocessed

A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced

US‑registered devices72in commercial distribution
Companies7labelers on GUDID
Single‑use83%of device records
Sterile24%labelled sterile
Prescription78%Rx‑only share
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Share of device records

Stryker Sustainability Solutions, Inc.2332%
Renu Medical, Inc1622%
Rashman Corporation1115%
Medline Industries, Inc.811%
Medsource International Llc710%
Covidien Lp57%
Masimo Corporation23%

Top labelers

CompanyDevicesShare
Stryker Sustainability Solutions, Inc.2332%
Renu Medical, Inc1622%
Rashman Corporation1115%
Medline Industries, Inc.811%
Medsource International Llc710%
Covidien Lp57%
Masimo Corporation23%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Stryker Sustainability SolutionsN/AWelch Allyn SPO2 SensorMedSource Neonatal Sensor, BCI (1/polybag)MedSource Hand Held Pulse Ox, DeluxeMedSource Pediatric Pulse Ox SensorMedSource Ped Pulse Oximeter, w/SPO2. PR, Pleth MedSource Pulse Oximeter, w/SPO2, PR, & Pleth WFMedSource SPO2 Sensor for Hand-HeldPulse Oximeter ProbeNellcor Pulse Oximeter ProbeMasimoMasimo Pulse Oximeter ProbePulse OximeterNellcorMedline

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

FDA product codes

CodeNameDevices
NLFOXIMETER, REPROCESSED55
NLFOximeter, Reprocessed32
DQAOximeter18
NLFOximeter, reprocessed12
DXNSystem, Measurement, Blood-Pressure, Non-Invasive1
MWIMonitor, Physiological, Patient (Without Arrhythmia Detectio1

GMDN & GCC registration

  • GMDN code 36087 · non‑implantable
  • Single‑use 83% · sterile 24% · Rx‑only 78% · OTC 6%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 8Length (Feet) · 2

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

How many pulse oximeter probe, reprocessed products are registered in the US?

72 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pulse oximeter probe, reprocessed", from 7 companies. The largest labeler is Stryker Sustainability Solutions, Inc. with 32% of records.

Which FDA product codes apply?

NLF (OXIMETER, REPROCESSED), NLF (Oximeter, Reprocessed), DQA (Oximeter), NLF (Oximeter, reprocessed)

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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