PMA P190007
- Device
- Cardinal Health Multifunctional Defibrillation Electrode
- Applicant
- Cardinalhealth
- PMA number
- P190007
- Product code
- MKJ
- Decision date
- 2020-08-07
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Approval for the Cardinal Health Multifunctional Defibrillation Electrodes. These devices are indicated for: The Multifunctional Defibrillation Electrodes are intended to transfer energy from a cardiac defibrillator or pacer to the body of a patient for the purpose of defibrillation, synchronized cardioversion, pacing, or for ECG monitoring. The Kendall and Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes with connectors intended for use with Physio-Control LIFEPAK (LP) defibrillators are compatible with Physio-Control / Stryker LP 15, LP 20, LP 20E, LP 1000, LP CR Plus, and LP Express defibrillators with the exception of the Kendall 1010P Adult Multi-Function Defibrillation Electrode, which is compatible with Physio-Control LP 20 and LP 20e defibrillators and the Physio-Control FAST-PATCH® cable.The Medi-Trace Cadence Pediatric Multi-Function Defibrillation Electrodes with connectors intended for use with Physio-Control / Stryker defibrillators are compatible with Physio-Control LP 15, LP 20, and LP 20e defibrillators.The Kendall and Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes with connectors intended for use with Zoll defibrillators are compatible with Zoll R Series BLS, R Series Plus, R Series ALS, X Series, and Propaq MD defibrillators.The Physio-Control/Stryker QUIK-COMBO Adult pacing/defibrillation/ECG electrodes and QUIK-COMBO Pediatric pacing/defibrillation/ECG electrodes are compatible with LP 15, LP 20, and LP 20e defibrillators. The Physio-Control/Stryker QUIK-COMBO pacing/defibrillation/ECG electrode with REDI-PAK Preconnect system is compatible with LP 15, LP 20, LP 20e, LP 1000, LP CR Plus, and LP EXPRESS defibrillators.
Current openFDA PMA Record#
- Device
- Cardinal Health Multifunctional Defibrillation Electrode
- Applicant
- Cardinalhealth
- PMA number
- P190007
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2020-08-07
- Decision code
- APPR
- Date received
- 2019-03-07
- Approval order statement
- Approval for the Cardinal Health Multifunctional Defibrillation Electrodes. These devices are indicated for: The Multifunctional Defibrillation Electrodes are intended to transfer energy from a cardiac defibrillator or pacer to the body of a patient for the purpose of defibrillation, synchronized cardioversion, pacing, or for ECG monitoring. The Kendall and Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes with connectors intended for use with Physio-Control LIFEPAK (LP) defibrillators are compatible with Physio-Control / Stryker LP 15, LP 20, LP 20E, LP 1000, LP CR Plus, and LP Express defibrillators with the exception of the Kendall 1010P Adult Multi-Function Defibrillation Electrode, which is compatible with Physio-Control LP 20 and LP 20e defibrillators and the Physio-Control FAST-PATCH® cable.The Medi-Trace Cadence Pediatric Multi-Function Defibrillation Electrodes with connectors intended for use with Physio-Control / Stryker defibrillators are compatible with Physio-Control LP 15, LP 20, and LP 20e defibrillators.The Kendall and Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes with connectors intended for use with Zoll defibrillators are compatible with Zoll R Series BLS, R Series Plus, R Series ALS, X Series, and Propaq MD defibrillators.The Physio-Control/Stryker QUIK-COMBO Adult pacing/defibrillation/ECG electrodes and QUIK-COMBO Pediatric pacing/defibrillation/ECG electrodes are compatible with LP 15, LP 20, and LP 20e defibrillators. The Physio-Control/Stryker QUIK-COMBO pacing/defibrillation/ECG electrode with REDI-PAK Preconnect system is compatible with LP 15, LP 20, LP 20e, LP 1000, LP CR Plus, and LP EXPRESS defibrillators.