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Device Explorer · FDA GUDID · GMDN 36550

Patient monitoring system module, blood pressure, invasive

A small unit dedicated to the measurement of invasive blood pressure (from one or more sites) obtained through a pressure transducer introduced directly into a blood vessel via a catheter. It is designed to operate as part of a patient monitoring system enhanc

US‑registered devices187in commercial distribution
Companies10labelers on GUDID
Single‑use1%of device records
Sterile1%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Metko Medikal Ve Tibbi Cihazlar Dis Ticaret Limited Sirketi16789%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.42%
Iradimed Corp.42%
Draeger Medical Systems, Inc.32%
Ge Healthcare Finland Oy21%
Mortara Instrument, Inc.21%
Medtronic, Inc.21%
Welch Allyn, Inc.11%

Top labelers

CompanyDevicesShare
Metko Medikal Ve Tibbi Cihazlar Dis Ticaret Limited Sirketi16789%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.42%
Iradimed Corp.42%
Draeger Medical Systems, Inc.32%
Ge Healthcare Finland Oy21%
Mortara Instrument, Inc.21%
Medtronic, Inc.21%
Welch Allyn, Inc.11%
Philips Medizin Systeme Böblingen Gmbh11%
Endophys Holdings, Llc11%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

IBP module(FDA/FJ/PK..)IBP module(FDA/PK.)IBP upgrd pkg/no accssryIBP upgrd pkg/with accssryWelch Allyn, Inc.INFINITY MCABLE-DUAL HEMOHemomed PodInfinity Mpod Quad HemoIBP ModuleIradimedEndophys Blood Pressure MonitorNASurveyor S12/S19 Patient CableTruSignal PRES MMDLP®FMT

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

FDA product codes

CodeNameDevices
IKDCable, Electrode167
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or7
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR5
MWIMonitor, Physiological, Patient (Without Arrhythmia Detectio4
DXSGAUGE, PRESSURE, CORONARY, CARDIOPULMONARY BYPASS3
DSKComputer, Blood-Pressure2

GMDN & GCC registration

  • GMDN code 36550 · non‑implantable
  • Single‑use 1% · sterile 1% · Rx‑only 97% · 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

Length (Centimeter) · 2

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

How many patient monitoring system module, blood pressure, invasive products are registered in the US?

187 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Patient monitoring system module, blood pressure, invasive", from 10 companies. The largest labeler is Metko Medikal Ve Tibbi Cihazlar Dis Ticaret Limited Sirketi with 89% of records.

Which FDA product codes apply?

IKD (Cable, Electrode), MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or), MHX (MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR), 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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