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Device Explorer · FDA GUDID · GMDN 36872

Multiple vital physiological parameter monitoring system, clinical

An assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIB

US‑registered devices363in commercial distribution
Companies17labelers on GUDID
Single‑use3%of device records
Sterile3%labelled sterile
Prescription66%Rx‑only share
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Share of device records

Lutech Industries Inc11030%
Welch Allyn, Inc.10930%
Zoe Medical Incorporated339%
Remote Diagnostic Technologies Limited247%
Philips Medizin Systeme Böblingen Gmbh144%
Mediblu Medical Llc123%
Icu Medical, Inc.123%
Spacelabs Healthcare (Washington), Inc103%

Top labelers

CompanyDevicesShare
Lutech Industries Inc11030%
Welch Allyn, Inc.10930%
Zoe Medical Incorporated339%
Remote Diagnostic Technologies Limited247%
Philips Medizin Systeme Böblingen Gmbh144%
Mediblu Medical Llc123%
Icu Medical, Inc.123%
Spacelabs Healthcare (Washington), Inc103%
Advanced Instrumentations, Inc.92%
Shenzhen Comen Medical Instruments Co., Ltd.62%
Criticare Technologies, Inc.62%
Athena Gtx, Inc.62%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

StarlingComenCOMENTempus ProPhilips IntelliSpace CorsiumTempus IC2Patient Monitor 6500Patient Monitor 6300Patient Monitor 6100IntelliVue Patient Monitor MX750IntelliVue Patient Monitor MX100IntelliVue Multi-Measurement Module X3IntelliVue Patient Monitor XG50IntelliVue Patient Monitor MX850IntelliVue MX550 Patient MonitorIntelliVue MX500 Patient Monitor

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

FDA product codes

CodeNameDevices
DQAOximeter153
MWIMonitor,Physiological,Patient(Without Arrhythmia Detection O153
DXNSystem, Measurement, Blood-Pressure, Non-Invasive145
FLLThermometer, Electronic, Clinical125
DPSElectrocardiograph118
MWIMONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION O92

GMDN & GCC registration

  • GMDN code 36872 · non‑implantable
  • Single‑use 3% · sterile 3% · Rx‑only 66% · 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 multiple vital physiological parameter monitoring system, clinical products are registered in the US?

363 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple vital physiological parameter monitoring system, clinical", from 17 companies. The largest labeler is Lutech Industries Inc with 30% of records.

Which FDA product codes apply?

DQA (Oximeter), MWI (Monitor,Physiological,Patient(Without Arrhythmia Detection O), DXN (System, Measurement, Blood-Pressure, Non-Invasive), FLL (Thermometer, Electronic, Clinical)

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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