Fusion1K

Basic Information

• Brand Name: Fusion1K
• Primary DI: 00817365020198
• Version / Model: FUS1K80
• Company Name: MOXI ENTERPRISES, LLC
• Labeler DUNS: 958807575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 39ebf390-0f2d-434a-9a7f-6444d3035699

Device Description

FUSION 1K SYSTEM 80"

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	880.5150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47520	Orthopaedic bed mattress	A large, durable, fabric case filled with a combination of layered resilient materials (e.g., foam rubber and gel) designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep, and to promote therapeutic postures in users suffering back maladies (e.g., spinal column compression, back pain) through the homogenous distribution of body weight.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817365020198	GS1