Powerheart® G5 Semi Automatic AED G5S-01A

GUDID 00812394020140

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

Cardiac Science Corporation

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

• Primary Device ID: 00812394020140
• NIH Device Record Key: 553df8d8-b7b1-4f64-b2d6-a0d327aa70f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Powerheart® G5 Semi Automatic AED
• Version Model Number: G5S-01A
• Catalog Number: G5S-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	00812394020140 [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

Devices Manufactured by Cardiac Science Corporation

• 00847946046118 - Sunmed: 2021-11-01 KIT, MASK, FLEX CPAP, #4, MEDIUM ADULT / HARNESS, SINGLE
• 00847946046125 - SunMed: 2021-11-01 KIT, MASK, FLEX CPAP, #5, LARGE ADULT / HARNESS, SINGLE
• 00847946046132 - Sunmed: 2021-11-01 KIT, MASK, FLEX CPAP, #6, X-LARGE ADULT / HARNESS, SINGLE
• 00847946046156 - Sunmed: 2021-11-01 MASK, FLEX CPAP, #4, MEDIUM ADULT, CASE OF 20
• 00847946046163 - Sunmed: 2021-11-01 MASK, FLEX CPAP, #5, LARGE ADULT, CASE OF 20
• 00847946046170 - Sunmed: 2021-11-01 MASK, FLEX CPAP, #6, X-LARGE ADULT, CASE OF 20
• 00847946046187 - Powerheart® G5 Electrodes: 2021-08-26 ELECTRODES, ADULT, G5 AED
• 00847946046194 - Powerheart® G5 Electrodes: 2021-08-26 ELECTRODES WITH CPR DEVICE, ADULT, G5 AED