Medi-Trace Combination Defibrillation & ECG Electrode

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Medi-Trace Combination Defibrillation & ECG Electrode for Physio Control Defibrillators

510(k) Number

K955828 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What clinical scenarios would this electrode be most useful in, and why?

  This Medi-Trace Combination Defibrillation & ECG Electrode is designed for emergency cardiac resuscitation and real-time ECG monitoring in settings where both defibrillation and diagnostic capabilities are required. It is particularly useful in pre-hospital environments, emergency rooms, and critical care units where clinicians need to deliver defibrillation shocks while simultaneously monitoring the patient’s heart rhythm. The dual functionality reduces the need for multiple electrodes, streamlining workflow and minimizing potential delays during critical interventions.

• How is this electrode packaged and what does a typical order include?

  The Medi-Trace Combination Defibrillation & ECG Electrode is supplied in pairs, with each pair packaged in individual heat-sealed pouches. This means a single order typically includes two electrodes per pouch, ensuring sterility and readiness for immediate use. The packaging ensures that each electrode remains protected until use, maintaining its pre-gelled and self-adhesive properties.

• Is this electrode reusable, or is it intended for single-use only? How does this affect its use?

  This electrode is explicitly designed for single-use only. It features a pre-gelled, self-adhesive hydrogel and is intended to be discarded after one use to ensure patient safety and sterility. Reusing single-use electrodes can compromise their performance, introduce infection risks, or lead to inaccurate ECG readings, which is why adherence to single-use guidelines is critical for reliable clinical outcomes.

• What storage conditions are recommended to maintain the electrode’s functionality?

  While the device data does not specify exact storage conditions, the electrode’s pre-gelled and self-adhesive properties suggest it should be stored in a cool, dry place away from direct sunlight or extreme temperatures. Heat-sealed pouches should remain intact until use to preserve sterility and prevent degradation of the adhesive or conductive hydrogel. Always check the packaging for expiration dates or storage instructions before use.

• Are there different sizes or models available for this electrode, and how would a clinician determine the correct fit?

  The provided data does not specify multiple sizes or models for this electrode, implying it is likely offered in a standard configuration designed to fit adult patients. However, clinicians should verify compatibility with the patient’s chest size and anatomy, as improper sizing can affect electrode adhesion, ECG signal quality, or defibrillation effectiveness. If pediatric or specialized use is required, additional validation or alternative electrodes may be necessary.