AED Manager, V.2.1.1.0 Powerheart G5 XAEDMGR01E

GUDID 00812394021314

Event Reporting and Administrative AED Configuration Software V.2.1.1.0 for Powerheart G5

CARDIAC SCIENCE CORPORATION

External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software External defibrillator application software

• Primary Device ID: 00812394021314
• NIH Device Record Key: e080ff6c-36b7-4a4c-a32b-5e5290d7b7f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AED Manager, V.2.1.1.0 Powerheart G5
• Version Model Number: XAEDMGR01E
• Catalog Number: XAEDMGR01E
• Company DUNS: 080355564
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com
• Phone: +1.262.953.3500
• Email: techsupport@cardiacscience.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812394020188 [Previous]
GS1	00812394021314 [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: 2017-03-02

Devices Manufactured by CARDIAC SCIENCE CORPORATION

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• 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