DDU-100 Lifeline AED with RX form and cabinet

GUDID 00815098020799

DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. Guide (DAC-A581-EN), 5 year battery pack with 9V Lithium battery (DCF-200), alarmed wall mount cabinet (DAC-220), rescue pack (DAC-420), 3-way wall sign (DAC-230), prescription activation form

DEFIBTECH, L.L.C.

Non-rechargeable public semi-automated external defibrillator

• Primary Device ID: 00815098020799
• NIH Device Record Key: b8ed60d7-96bf-4ad1-ad83-86eee5ed4b73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DDU-100 Lifeline AED with RX form and cabinet
• Version Model Number: CCPRX-0001
• 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	00815098020799 [Primary]

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: 2021-08-09
• Device Publish Date: 2021-07-30

On-Brand Devices [DDU-100 Lifeline AED with RX form and cabinet]

• 00815098020805: DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. G
• 00815098020799: DDU-100 Lifeline AED, US, English, 1 set Adult Pads (DDP-100), Quick Start Card (DAC-501), Op. G