Fusion2K

GUDID 00817365020327

FUSION SYSTEM - W/FULL LAL

MOXI ENTERPRISES, LLC

Low-air-loss bed
Primary Device ID00817365020327
NIH Device Record Key59c52b02-3cbb-4b9b-96f3-7c5e3e29b203
Commercial Distribution Discontinuation2016-08-26
Commercial Distribution StatusNot in Commercial Distribution
Brand NameFusion2K
Version Model NumberFUSIONCA
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
GS100817365020327 [Primary]

FDA Product Code

FNMMattress, Air Flotation, Alternating Pressure

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 Date2016-08-11

On-Brand Devices [Fusion2K]

00817365020327FUSION SYSTEM - W/FULL LAL
00817365020303FUSION 2K SYSTEM, CUSTOM SIZE
00817365020297FUSION 2K CONVERSION KIT (FUSLAL2, SAHYBPUMP)
00817365020280FUSION 2K SYSTEM 84" French Canadian
00817365020273FUSION 2K SYSTEM 84" W/FR COVER
00817365020266FUSION 2K SYSTEM 84"
00817365020259FUSION 2K SYSTEM 80" French Canadian
00817365020242FUSION 2K SYSTEM 80"
00817365020235FUSION 2K SYSTEM 39x80"

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