Consulting Wallah › Device Explorer › Catheters & tubes › Cardiac catheterization monitoring system
Device Explorer · FDA GUDID · GMDN 37807

Cardiac catheterization monitoring system

An assembly of devices designed to continuously obtain, amplify, and record various signals generated during procedures usually performed in the cardiac catheterization laboratory. It typically consists of a computerized central workstation including a monitor

US‑registered devices92in commercial distribution
Companies5labelers on GUDID
Single‑use3%of device records
Sterile0%labelled sterile
Prescription97%Rx‑only share
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Share of device records

St. Jude Medical, Inc.7177%
Ge Medical Systems Information Technologies, Inc.910%
Icu Medical, Inc.55%
Fysicon B.V.55%
Epiep, Inc.22%

Top labelers

CompanyDevicesShare
St. Jude Medical, Inc.7177%
Ge Medical Systems Information Technologies, Inc.910%
Icu Medical, Inc.55%
Fysicon B.V.55%
Epiep, Inc.22%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

WorkMate™ Unity™WorkMate Claris™WorkMate™ Scribe™WorkMate™ Claris™WorkMate™EP-WorkMate™ViewFlex™EP-4™EP-NurseMate™ICU MedicalComboLabMac-LabCardioLabCLAB II Plus AmplifierMLCL Client SoftwareEpiAccess Control Unit

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

FDA product codes

CodeNameDevices
DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE57
DQKComputer, diagnostic, programmable27
DQKComputer, Diagnostic, Programmable8
MWIMonitor, Physiological, Patient (Without Arrhythmia Detectio5
DQAOximeter3
DXGCOMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION2

GMDN & GCC registration

  • GMDN code 37807 · non‑implantable
  • Single‑use 3% · sterile 0% · 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 (Meter) · 3Height (Inch) · 1Depth (Inch) · 1Width (Inch) · 1Weight (Pound) · 1

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

How many cardiac catheterization monitoring system products are registered in the US?

92 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiac catheterization monitoring system", from 5 companies. The largest labeler is St. Jude Medical, Inc. with 77% of records.

Which FDA product codes apply?

DQK (COMPUTER, DIAGNOSTIC, PROGRAMMABLE), DQK (Computer, diagnostic, programmable), DQK (Computer, Diagnostic, Programmable), 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.

How do I get quotes?

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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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