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Cardinal Health Multifunctional Defibrillation Electrode

FDA PMA

Class III (US FDA PMA)

PMA P190007

by Cardinalhealth

Identity

Trade Name
Cardinal Health Multifunctional Defibrillation Electrode FDA PMA
Generic Name
Automated external defibrillators (non-wearable) FDA PMA

Identifiers

PMA Number
P190007 FDA PMA
FDA Product Code
MKJ FDA PMA

Classification

Device Class
Class III FDA PMA
Legislation / Framework
21 CFR Part 870.5310 FDA PMA
Regulation Number
870.5310 FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA

The Cardinal Health Multifunctional Defibrillation Electrode is a medical device designed to transfer energy from a cardiac defibrillator or pacer to a patient. These electrodes are indicated for use in defibrillation, synchronized cardioversion, pacing, or for ECG monitoring procedures.

These electrodes are available in various configurations compatible with specific Physio-Control, Stryker, and Zoll defibrillator models. The product range includes adult and pediatric options, including versions with the REDI-PAK Preconnect system. This device has received FDA PMA authorization.

Frequently asked questions

What are the Cardinal Health Multifunctional Defibrillation Electrodes used for?

These electrodes are intended to transfer energy from a cardiac defibrillator or pacer to a patient's body for the purposes of defibrillation, synchronized cardioversion, pacing, or ECG monitoring.

Are these electrodes compatible with all defibrillators?

No, compatibility depends on the specific electrode model and connector type. The product line is designed for use with specific Physio-Control, Stryker, and Zoll defibrillator systems, such as the LP 15, LP 20, and various Zoll R Series or X Series devices.

Does this product include pediatric options?

Yes, the product line includes Medi-Trace Cadence Pediatric Multi-Function Defibrillation Electrodes and QUIK-COMBO Pediatric pacing/defibrillation/ECG electrodes, which are compatible with specific Physio-Control and Stryker defibrillator models.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cardinal Health Deutschland, Cardinal Health Germany 507 GmbH - Meier-Medizintechnik GmbH

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Cardinalhealth

Sources (1)

  • FDA PMA P190007 24 fields · synced Sep 18, 2026