Fusion 2KXL FUS4284COV

GUDID 00817365022208

Fusion 2KXL Outer Cover 42x84x8

MOXI ENTERPRISES, LLC

Waterproof bed mattress cover, reusable
Primary Device ID00817365022208
NIH Device Record Key68d92a93-7433-4d65-9eba-c6ede5ab278d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFusion 2KXL
Version Model NumberFUS4284COV
Catalog NumberFUS4284COV
Company DUNS958807575
Company NameMOXI ENTERPRISES, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone314-771-5222
Emailinfo@moxiusa.com
Phone314-771-5222
Emailinfo@moxiusa.com
Phone314-771-5222
Emailinfo@moxiusa.com
Phone314-771-5222
Emailinfo@moxiusa.com
Phone314-771-5222
Emailinfo@moxiusa.com
Phone314-771-5222
Emailinfo@moxiusa.com
Phone314-771-5222
Emailinfo@moxiusa.com
Phone314-771-5222
Emailinfo@moxiusa.com
Phone314-771-5222
Emailinfo@moxiusa.com
Phone314-771-5222
Emailinfo@moxiusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817365022208 [Primary]

FDA Product Code

FMWCover, Mattress (Medical Purposes)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-14
Device Publish Date2022-11-04

On-Brand Devices [Fusion 2KXL]

00817365022215Fusion 2KXL Outer Cover 48x80x8
00817365022208Fusion 2KXL Outer Cover 42x84x8
00817365022192Fusion 2KXL Outer Cover 42x80x8

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.