Powerheart G5 Semi Automatic AED G5S-01-L

GUDID 00812394021253

Powerheart G5 AED, Semi Automatic, Loaner, English

CARDIAC SCIENCE CORPORATION

Non-rechargeable public semi-automated external defibrillator

• Primary Device ID: 00812394021253
• NIH Device Record Key: f0c4c8c3-52ce-461a-8f84-35fe55964fe3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Powerheart G5 Semi Automatic AED
• Version Model Number: G5S-01-L
• Catalog Number: G5S-01-L
• 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: 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
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812394021253 [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: 2017-02-15

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