ELECT ASSY-PED RTS,WORLDWIDE,3RD EDITION


Product Overview

ELECT ASSY
Pediatric EDGE System RTS Electrodes with QUIK-COMBO Connector - 11996


Device Description

An electrical conductor used in pairs to transmit a controlled electrical shock from an external defibrillator to a post-pubescent patient in order to defibrillate the heart (restore a normal rhythm) or slow a rapid heart rate. It typically consists of a cable set [with a connector for insertion into the external pulse generator (EPG)] that terminates with self-affixing pads (the electrodes) prefabricated with contact gel and an adhesive, that are applied to the chest (the intact torso) of the patient so that the discharge passes across the region of the heart. This device may remain applied to the patient during stages of treatment. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: MKJ

Device Name: Automated External Defibrillators (Non-Wearable)

Device Class: 3

Physical State: N/A

Definition: This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold with prescription only.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.5310

Third Party Flag: N

Medical Specialty: CV


Device Identifiers

Device Id: 00721902207501

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


Device Id: 40721902207509

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20721902207505

Package Quantity: 25

Package Discontinue Date: 11/2/2020 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Case


Device Id: 20721902207505

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00721902207501

Package Quantity: 5

Package Discontinue Date: 11/2/2020 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Shelf Pak


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