DDU-1XXX/2XXX Series Battery Pack

GUDID 00815098020416

DEFIBTECH, L.L.C.

Primary battery Primary battery

• Primary Device ID: 00815098020416
• NIH Device Record Key: f4a17bc8-5e2a-464b-921c-2a6911a9814e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DDU-1XXX/2XXX Series Battery Pack
• Version Model Number: DBP-2013
• 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: 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	00815098020416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081259

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 [DDU-1XXX/2XXX Series Battery Pack]

• 00815098020416: DBP-2013
• 00815098020393: DBP-2003