ASSY-LP CR PLUS, AUTO,BREATHING

ASSY
LIFEPAK CR Plus and LIFEPAK Express defibrillators - 99403

Device Description

A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it automatically activates defibrillation of the heart through application of electrical shocks to the chest surface. The device is placed in conspicuous public locations and is intended to be applied to the patient by a layperson. It consists of an external pulse generator (EPG) with a cardiac rhythm recognition system and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it includes internal rechargeable batteries for energy that must be charged when not in use.

Environmental Conditions

Handling Environment Humidity - Percent (%) Relative Humidity

95.00
5.00

Handling Environment Temperature - Degrees Celsius

70.00
-40.00

Special Storage Condition, Specify

Storage at extreme temperatures of -40C to 70C (-40F to 158F) is limited to 7 days. If storage at these temperatures exceeds one week, the electrode shelf-life is reduced.

Storage Environment Humidity - Percent (%) Relative Humidity

95.00
5.00

Storage Environment Temperature - Degrees Celsius

35.00
15.00

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: 00721902462948

Device Type: Previous

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