Powerheart® AED G3 Plus Automatic AED 9390A-1001

GUDID 00812394020232

G3Plus, AED, Automatic ,AHA 2010, with adult pads and battery

Cardiac Science Corporation

Non-rechargeable public automated external defibrillator

• Primary Device ID: 00812394020232
• NIH Device Record Key: 97f296f7-dfe6-4ccf-ac83-7f7c77b88d9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Powerheart® AED G3 Plus Automatic AED
• Version Model Number: 9390A-1001
• Catalog Number: 9390A-1001
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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 Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812394020232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102496

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: 2014-09-29

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• 00812394020379: G3Plus, AED, Automatic, AHA 2010, with adult pads and TSO battery
• 00812394020362: G3Plus, AED, Automatic, AHA 2010, with adult pads and battery
• 00812394020331: G3 Plus, AED, Automatic, AHA 2010
• 00812394020232: G3Plus, AED, Automatic ,AHA 2010, with adult pads and battery
• 00812394023288: G3Plus, AED, Automatic ,AHA 2010, with adult pads and battery
• 00812394023271: G3 Plus, AED, Automatic, AHA 2010
• 00812394023301: G3Plus, AED, Automatic, AHA 2010, with adult pads and TSO battery