AED Brands, LLC

GUDID 00865292000127

Battery for use with Cardiac Science(TM) G3 series AEDs

AED BRANDS, LLC

Primary battery

• Primary Device ID: 00865292000127
• NIH Device Record Key: 5839323e-f31c-4107-bf49-234bd3ee0cea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AED Brands, LLC
• Version Model Number: AB 9146-302
• Company DUNS: 611739603
• Company Name: AED BRANDS, LLC
• 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: true
• 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: 770-425-5840
• Email: mczabala@aedbrands.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865292000127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082861

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: 2015-06-05

On-Brand Devices [AED Brands, LLC]

• 00865292000141: Battery for use with Cardiac Science AEDs
• 00865292000127: Battery for use with Cardiac Science(TM) G3 series AEDs
• 90865292000106: Adult electrodes for use with Cardiac Science(TM) AEDs - Can be used in place of Cardiac Science