Powerheart® G5 Semi Automatic AED G5S-01P0

GUDID 00812394020041

Powerheart® G5 Semi-Automatic AED

Cardiac Science Corporation

Non-rechargeable public semi-automated external defibrillator

• Primary Device ID: 00812394020041
• NIH Device Record Key: a67b6319-855f-4885-a591-15f7b5973f7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Powerheart® G5 Semi Automatic AED
• Version Model Number: G5S-01P0
• Catalog Number: G5S-01P0
• 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: true
• 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 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812394020041 [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: 2015-01-01

On-Brand Devices [Powerheart® G5 Semi Automatic AED]

• 00812394021260: Powerheart® G5 Semi-Automatic AED no battery or pads
• 00812394021246: Powerheart G5 AED, Semi Automatic, English, with Intellisense Adult Pads with CPR feedback devic
• 00812394021239: Powerheart G5 AED, Semi Automatic, English, with Intellisense Adult Pads and Battery
• 00812394020041: Powerheart® G5 Semi-Automatic AED
• 00812394023141: Powerheart® G5 Semi Automatic AED no battery or pads