Consulting Wallah › Device Explorer › Catheters & tubes › Intracardiac catheter-tip electrode
Device Explorer · FDA GUDID · GMDN 11434

Intracardiac catheter-tip electrode

An electrical conductor located at one end of an appropriate flexible catheter (not included) which is inserted into the chambers of the heart in order for the electrode to detect the presence of certain indicators to measure cardiac output. The relayed signal

US‑registered devices391in commercial distribution
Companies2labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Access Point Technologies, Inc.38699%
Cd Leycom51%

Top labelers

CompanyDevicesShare
Access Point Technologies, Inc.38699%
Cd Leycom51%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Map-iT1285995657 Fr PV-Catheter4 Fr PV Catheter

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

FDA product codes

CodeNameDevices
DRFCatheter, Electrode Recording, Or Probe, Electrode Recording386
OBJCatheter, Ultrasound, Intravascular5
DQOCatheter, Intravascular, Diagnostic5

GMDN & GCC registration

  • GMDN code 11434 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · 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) · 386Catheter Gauge (French) · 380

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

How many intracardiac catheter-tip electrode products are registered in the US?

391 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intracardiac catheter-tip electrode", from 2 companies. The largest labeler is Access Point Technologies, Inc. with 99% of records.

Which FDA product codes apply?

DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), OBJ (Catheter, Ultrasound, Intravascular), DQO (Catheter, Intravascular, Diagnostic)

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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