Powerheart G5 Kit, Semi, US Eng/ESP LA G5S-80P0

GUDID 00812394020560

Powerheart G5 AED, Semi Automatic, Dual Language (English/Spanish),no battery or pads

Cardiac Science Corporation

Non-rechargeable public semi-automated external defibrillator

• Primary Device ID: 00812394020560
• NIH Device Record Key: 7dc80883-6614-416f-87f9-75376288bb21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Powerheart G5 Kit, Semi, US Eng/ESP LA
• Version Model Number: G5S-80P0
• Catalog Number: G5S-80P0
• 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: 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	00812394020560 [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: 2015-04-29

On-Brand Devices [Powerheart G5 Kit, Semi, US Eng/ESP LA]

• 00812394021284: Powerheart G5 AED, Semi Automatic, Dual Language (English/Spanish), with Intellisense Adult Pads
• 00812394021277: Powerheart G5 AED, Semi Automatic, Dual Language (English/Spanish), with Intellisense Adult Pads
• 00812394020560: Powerheart G5 AED, Semi Automatic, Dual Language (English/Spanish),no battery or pads
• 00812394020553: Powerheart G5 AED, Semi Automatic, Dual Language (English/Spanish),with Intellisense Adult Pads