Lifeline ECG 2

GUDID 00815098021536

DEFIBTECH, L.L.C.

Non-rechargeable professional semi-automated external defibrillator

• Primary Device ID: 00815098021536
• NIH Device Record Key: 3a2deae2-1af4-43aa-b74e-fcbce9c875d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lifeline ECG 2
• Version Model Number: DDU-2960
• 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	00815098021536 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160032

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: 2025-12-17
• Device Publish Date: 2025-12-09

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
• 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