Avive Pad Cartridge

GUDID 00860002508528

Avive Solutions, Inc.

Rechargeable public automated external defibrillator Rechargeable public automated external defibrillator Rechargeable public automated external defibrillator Rechargeable public automated external defibrillator Rechargeable public automated external defibrillator Rechargeable public automated external defibrillator Rechargeable public automated external defibrillator Rechargeable public automated external defibrillator Rechargeable public automated external defibrillator Rechargeable public automated external defibrillator Rechargeable public automated external defibrillator Rechargeable public automated external defibrillator Rechargeable public automated external defibrillator Rechargeable public automated external defibrillator Rechargeable public automated external defibrillator Rechargeable public automated external defibrillator Rechargeable public automated external defibrillator

• Primary Device ID: 00860002508528
• NIH Device Record Key: 19e566d4-bcc8-42fa-b6ca-13ef954a8967
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avive Pad Cartridge
• Version Model Number: ACC01
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00860002508528 [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
• 00860002508528 - Avive Pad Cartridge: 2024-02-28
• 00860002508559 - Avive AED with Avive Connect: 2024-02-28