Lifeline ECG

GUDID 00815098020317

DEFIBTECH, L.L.C.

Non-rechargeable professional semi-automated external defibrillator

• Primary Device ID: 00815098020317
• NIH Device Record Key: 7a1e4e7b-3fbf-4f46-9d51-35f842be0478
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lifeline ECG
• Version Model Number: DDU-E2450
• 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	00815098020317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121853

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: 2015-10-24

On-Brand Devices [Lifeline ECG]

• 00815098020317: DDU-E2450
• 00815098020287: DDU-A2450