Fusion1K

GUDID 00817365020198

FUSION 1K SYSTEM 80"

MOXI ENTERPRISES, LLC

Orthopaedic bed mattress

• Primary Device ID: 00817365020198
• NIH Device Record Key: 39ebf390-0f2d-434a-9a7f-6444d3035699
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion1K
• Version Model Number: FUS1K80
• Company DUNS: 958807575
• Company Name: MOXI ENTERPRISES, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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	00817365020198 [Primary]

FDA Product Code

• IKY: Mattress, Flotation Therapy, Non-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-09

On-Brand Devices [Fusion1K]

• 00817365020310: FUSION CUSTOM SYSTEM
• 00817365020228: FUSION 1K SYSTEM 84" W/FR COVER
• 00817365020211: FUSION 1K SYSTEM 84"
• 00817365020204: FUSION 1K SYSTEM 80" w/visco heal
• 00817365020198: FUSION 1K SYSTEM 80"