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LIFEPAK 1000 defibrillator - 99425

Device Description

A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, and to audibly/visually instruct an operator to enable it to activate defibrillation of the heart or allow the operator to decide when to activate defibrillation based on its electrocardiogram display. It is intended to be used by healthcare professionals (e.g., paramedics, medical staff) in healthcare settings. It consists of an external pulse generator (EPG) and skin-adhesive electrodes to monitor the rhythm/deliver the shocks; it has internal non-rechargeable batteries that must be replaced when indicated.

Environmental Conditions

Handling Environment Humidity - Percent (%) Relative Humidity

95.00
5.00

Handling Environment Temperature - Degrees Celsius

50.00
-20.00

Special Storage Condition, Specify

Storage at extreme temperatures of -30C to 60C (-22F to 140F) 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

25.00
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: 00885074630472

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

Device Id: 00883873815434

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

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