Avive AED with Avive Connect

GUDID 00860002508559

Avive Solutions, Inc.

Rechargeable public automated external defibrillator

• Primary Device ID: 00860002508559
• NIH Device Record Key: d9690f6e-54df-4965-a21f-8ec9aea666bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avive AED with Avive Connect
• Version Model Number: AED01
• Company DUNS: 080888495
• Company Name: Avive Solutions, Inc.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002508559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P210015

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-28
• Device Publish Date: 2024-02-20

Devices Manufactured by Avive Solutions, Inc.

• 00860002508528 - Avive Pad Cartridge: 2024-02-28
• 00860002508559 - Avive AED with Avive Connect: 2024-02-28
• 00860002508559 - Avive AED with Avive Connect: 2024-02-28