FUSXC80VIS-4HNS

GUDID 00817365021140

FUSION XC 80" SYSTEM W/VISCO HEEL & 1" VISCO NON-SLOPE TOP W/HANDLES

MOXI ENTERPRISES, LLC

Orthopaedic bed mattress Orthopaedic bed mattress Orthopaedic bed mattress
Primary Device ID00817365021140
NIH Device Record Key8353de1a-42d1-4874-8b56-2aef06c740f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameFUSXC80VIS-4HNS
Version Model NumberFUSXC80VIS-4HNS
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
GS100817365021140 [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 Date2016-12-07

Devices Manufactured by MOXI ENTERPRISES, LLC

00817365021683 - SelectAir2023-04-06 G5 SelectAir Standard pump US
00817365021690 - SelectAir2023-04-06 G5 SelectAir MAX+ pump US
00817365021706 - SelectAir2023-04-06 G5 HybridSelect/Fusion pump US
00817365021355 - SelectAir2022-11-14 SelectAir 54x85x10 No Foot Pillow Long Cover
00817365021522 - SelectAir2022-11-14 SelectAir Standard Select Protect Raised Edge Cover w/Footpillow and stretch top 36x84x8
00817365021591 - SelectAir2022-11-14 SelectAir Standard Cover No Foot, Long 36x85x8
00817365021812 - SelectAir2022-11-14 SelectAir First Care Overlay Sheet 36x80x4
00817365021829 - SelectAir2022-11-14 SelectAir Cover w/foot pillow 39x84x8

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