Powerheart® AED G3 Automatic AED 9300A-01

GUDID 00812394020195

G3, AED, Automatic, AHA 2010

Cardiac Science Corporation

Non-rechargeable public automated external defibrillator

• Primary Device ID: 00812394020195
• NIH Device Record Key: 66c0b80e-813a-4409-931a-8ce87ef2909c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Powerheart® AED G3 Automatic AED
• Version Model Number: 9300A-01
• Catalog Number: 9300A-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	00812394020195 [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 Automatic AED]

• 00812394021017: G3, AED, Automatic, AHA 2010, TSO with adult pads and TSO battery
• 00812394021000: G3, AED, Automatic, AHA 2010
• 00812394020195: G3, AED, Automatic, AHA 2010
• 00812394020065: G3, AED, Automatic, AHA 2010, TSO with adult pads and TSO battery
• 00812394023189: G3, AED, Automatic, AHA 2010, TSO with adult pads and TSO battery
• 00812394023172: G3, AED, Automatic, AHA 2010