Fusion 2K FUS3980COV

GUDID 00817365022178

Fusion 2K Cover 39x80x6

MOXI ENTERPRISES, LLC

Waterproof bed mattress cover, reusable

• Primary Device ID: 00817365022178
• NIH Device Record Key: cdd97661-db02-4d36-82d3-b81d3fee8ff4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion 2K
• Version Model Number: FUS3980COV
• Catalog Number: FUS3980COV
• 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: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 314-771-5222
• Email: info@moxiusa.com
• Phone: 314-771-5222
• Email: info@moxiusa.com
• Phone: 314-771-5222
• Email: info@moxiusa.com
• Phone: 314-771-5222
• Email: info@moxiusa.com
• Phone: 314-771-5222
• Email: info@moxiusa.com
• Phone: 314-771-5222
• Email: info@moxiusa.com
• Phone: 314-771-5222
• Email: info@moxiusa.com
• Phone: 314-771-5222
• Email: info@moxiusa.com
• Phone: 314-771-5222
• Email: info@moxiusa.com
• Phone: 314-771-5222
• Email: info@moxiusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817365022178 [Primary]

FDA Product Code

• FMW: Cover, Mattress (Medical Purposes)

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: 2022-11-14
• Device Publish Date: 2022-11-04

On-Brand Devices [Fusion 2K]

• 00817365021607: Fusion 2K XL 48x80x8
• 00817365020306: Fusion 2K XL 48x80x8 Canada
• 00817365020305: Fusion 2K XL 42x80x8 Canada
• 00817365020304: Fusion 2K XL 42x80x8
• 00817365021669: Fusion 2K XL 42 x 84 x 8
• 00817365021652: Fusion 2K XL 48x84x8
• 00817365021638: Fusion 2K XL 42x80x8
• 00817365022246: Fusion APT Outer Cover 35x80x6
• 00817365022239: Fusion 2K Outer Cover 35x84x6
• 00817365022222: Fusion 2K Outer Cover 35x80x6
• 00817365022185: Fusion 2K Cover 39x84x6
• 00817365022178: Fusion 2K Cover 39x80x6