Powerheart® AED G3 Plus Semi-Automatic AED 9390E-01

GUDID 00812394020348

G3 Plus, AED, Semi-Automatic, AHA 2010

Cardiac Science Corporation

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

• Primary Device ID: 00812394020348
• NIH Device Record Key: 878d9dc6-892f-4366-b487-bd5fdb43e210
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Powerheart® AED G3 Plus Semi-Automatic AED
• Version Model Number: 9390E-01
• Catalog Number: 9390E-01
• 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: 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 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	00812394020348 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-29

On-Brand Devices [Powerheart® AED G3 Plus Semi-Automatic AED]

• 00812394021116: G3 Plus, AED, Semi-Automatic, AHA 2010
• 00812394020348: G3 Plus, AED, Semi-Automatic, AHA 2010
• 00812394023318: G3 Plus, AED, Semi-Automatic, AHA 2010