ReviveR Configuration

GUDID 10815098020024

DEFIBTECH, L.L.C.

Non-rechargeable public semi-automated external defibrillator

• Primary Device ID: 10815098020024
• NIH Device Record Key: 2bf18dbe-a859-4706-8bc8-acaf003eacf9
• Commercial Distribution Discontinuation: 2024-08-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ReviveR Configuration
• Version Model Number: DDU-100B
• Company DUNS: 128340200
• Company Name: DEFIBTECH, L.L.C.
• 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: false
• 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	10815098020024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013896

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: 4
• Public Version Date: 2025-03-26
• Device Publish Date: 2015-10-24

Devices Manufactured by DEFIBTECH, L.L.C.

• 00815098021482 - Lifeline VIEW 2: 2025-12-17
• 00815098021512 - Lifeline VIEW 2 Auto: 2025-12-17
• 00815098021536 - Lifeline ECG 2: 2025-12-17
• 00815098021550 - DDU-29XX series, universal pad, single pair: 2025-12-17
• 10815098021496 - Lifeline VIEW 2 AED configuration: 2025-12-17
• 10815098021526 - Lifeline VIEW 2 AUTO AED configuration: 2025-12-17
• 10815098021540 - Lifeline ECG 2 AED configuration: 2025-12-17
• 30815098021568 - Pads, DDU-29XX series, universal pad, 10 pairs: 2025-12-17