Fusion1K

GUDID 00817365020228

FUSION 1K SYSTEM 84" W/FR COVER

MOXI ENTERPRISES, LLC

Orthopaedic bed mattress
Primary Device ID00817365020228
NIH Device Record Keye8c9b3ed-e52b-4d9a-bd56-2fba45e0e166
Commercial Distribution Discontinuation2016-08-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameFusion1K
Version Model NumberFUS1K84-FR
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817365020228 [Primary]

FDA Product Code

IKYMattress, Flotation Therapy, Non-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-09

On-Brand Devices [Fusion1K]

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

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