Powerheart® G5 Automatic AED G5A-01A

GUDID 00812394020157

Powerheart® G5 Automatic AED. Package includes: Powerheart® G5 Automatic AED, battery, set of adult defibrillation pads and AED manager

Cardiac Science Corporation

Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator

• Primary Device ID: 00812394020157
• NIH Device Record Key: 103fcf0f-840e-4f3b-9786-85ea4bb4e9b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Powerheart® G5 Automatic AED
• Version Model Number: G5A-01A
• Catalog Number: G5A-01A
• Company DUNS: 190713797
• Company Name: Cardiac Science Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 570 KiloPascal and 1060 KiloPascal
• Storage Environment Atmospheric Pressure: Between 570 KiloPascal and 1060 KiloPascal
• Storage Environment Atmospheric Pressure: Between 570 KiloPascal and 1060 KiloPascal
• Storage Environment Atmospheric Pressure: Between 570 KiloPascal and 1060 KiloPascal
• Storage Environment Atmospheric Pressure: Between 570 KiloPascal and 1060 KiloPascal
• Storage Environment Atmospheric Pressure: Between 570 KiloPascal and 1060 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812394020157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122758

FDA Product Code

• MKJ: Automated External Defibrillators (Non-Wearable)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-01-01

On-Brand Devices [Powerheart® G5 Automatic AED]

• 00812394021185: Powerheart® G5 Automatic AED no battery or pads
• 00812394021161: Powerheart G5 AED, Fully Automatic, English, with Intellisense Adult Pads with CPR feedback devi
• 00812394021154: Powerheart G5 AED, Fully Automatic, English, with Intellisense Adult Pads and Battery
• 00812394020164: Powerheart® G5 Automatic AED
• 00812394020157: Powerheart® G5 Automatic AED. Package includes: Powerheart® G5 Automatic AED, battery, set
• 00812394023134: Powerheart® G5 Automatic AED no battery or pads