Full Power AED

GUDID 00867855000308

Adhesive Medical Device to remove chest hair before defibrillation

FULL POWER AED, LLC

Hypoallergenic skin adhesive tape

• Primary Device ID: 00867855000308
• NIH Device Record Key: 542a3ebe-64b0-4e2f-be2a-0e2b727f3064
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Full Power AED
• Version Model Number: Rapid Hair Removal Pads
• Company DUNS: 075191245
• Company Name: FULL POWER AED, LLC
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9194756088
• Email: jahnpower@fullpoweraed.com

Device Dimensions

• Height: 7.95 Inch
• Height: 7.95 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867855000308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150349

FDA Product Code

• LDD: Dc-Defibrillator, Low-Energy, (Including Paddles)

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: 2019-10-23
• Device Publish Date: 2017-04-12