Consulting Wallah › Device Explorer › Other devices › Electrocardiographic lead set, reprocessed
Device Explorer · FDA GUDID · GMDN 61812

Electrocardiographic lead set, reprocessed

A collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulate

US‑registered devices166in commercial distribution
Companies4labelers on GUDID
Single‑use94%of device records
Sterile2%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Medline Industries, Inc.4728%
Renu Medical, Inc4527%
Cardinal Health 200, Llc4125%
Stryker Sustainability Solutions, Inc.3320%

Top labelers

CompanyDevicesShare
Medline Industries, Inc.4728%
Renu Medical, Inc4527%
Cardinal Health 200, Llc4125%
Stryker Sustainability Solutions, Inc.3320%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

N/AKendall ECG LeadsAdvantage Medical Cable ECG LeadsPhilips ECG LeadPhilipsDraeger 5-Lead ECG - ReprocessedAdvantage Medical Cable ECG LeadECG LeadECG LeadsCovidien ECG LeadsSustainable TechnologiesMEDLINEMedlineMEDLINE RENEWAL

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

FDA product codes

CodeNameDevices
IKDCABLE, ELECTRODE161
IKDCable, Electrode70

GMDN & GCC registration

  • GMDN code 61812 · non‑implantable
  • Single‑use 94% · sterile 2% · 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 (Feet) · 62Length (Inch) · 4

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

How many electrocardiographic lead set, reprocessed products are registered in the US?

166 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electrocardiographic lead set, reprocessed", from 4 companies. The largest labeler is Medline Industries, Inc. with 28% of records.

Which FDA product codes apply?

IKD (CABLE, ELECTRODE), IKD (Cable, Electrode)

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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