EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS

Primary DI

08809435482090

Basic UDI-DI Code

B-08809435482090

Reference

CUA0512F

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

CU Medical Systems, Inc.

The “Defibrillation Electrodes” (hereinafter Pads) are disposable defibrillation electrode pads designed for use with defibrillator manufactured by CU Medical Systems, Inc. They are used in the acquisition of electrocardiogram (ECG) and delivery of defibrillation shocks Using a pads attached to the chest, the defibrillator can apply electrical energy of max to the heart to remove ventricular fibrillation or ventricular tachycardia. The pads are for defibrillation use only. They are not designed for pacing, monitoring, or synchronized cardioversion. They are also disposable and for single use only.

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).