LX9max

GUDID 18809315675021

Main device 1ea, LEG SLEEVE Large 2ea, Single Hose 1ea, Double Hose 1ea [One set box]

DAESUNG MAREF CO.,LTD.

Intermittent venous compression system
Primary Device ID18809315675021
NIH Device Record Key8989a1aa-9ade-4ab8-8f9e-15e14fbdff77
Commercial Distribution StatusIn Commercial Distribution
Brand NameLX9max
Version Model NumberLX9M200-BL-2
Company DUNS688817949
Company NameDAESUNG MAREF CO.,LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS108809315675024 [Primary]
GS118809315675021 [Package]
Contains: 08809315675024
Package: Box [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IRPMassager, Powered Inflatable Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-22
Device Publish Date2021-12-14

On-Brand Devices [LX9max]

08809315675864Main device 1ea, CENTER BODY SLEEVE 1ea, CENTER BODY EXTENSION ZIPPER 1ea, Double Hose 1ea, Reco
08809315675857Main device 1ea, LEG SLEEVE XXLarge 2ea, WAIST SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea, Dis
08809315675840Main device 1ea, LEG SLEEVE XLarge 2ea, WAIST SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea, Dist
08809315675833Main device 1ea, LEG SLEEVE Large 2ea, WAIST SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea, Distr
08809315675291Main device 1ea, LEG SLEEVE XXLarge 2ea, WAIST SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea, Rec
08809315675284Main device 1ea, LEG SLEEVE XLarge 2ea, WAIST SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea, Reco
08809315675277Main device 1ea, LEG SLEEVE Large 2ea, WAIST SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea, Recov
08809315675260Main device 1ea, LEG SLEEVE XXLarge 2ea, ARM SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea, Recov
08809315675253Main device 1ea, LEG SLEEVE XLarge 2ea, ARM SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea, Recove
08809315675246Main device 1ea, LEG SLEEVE Large 2ea, ARM SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea, Recover
08809315675239Main device 1ea, ARM SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea, Recovery Bag 1ea [One set bo
08809315675222Main device 1ea, LEG SLEEVE XXLarge 2ea, ARM SLEEVE 1ea, WAIST SLEEVE 1ea, Single Hose 1ea, Doub
08809315675215Main device 1ea, LEG SLEEVE XLarge 2ea, ARM SLEEVE 1ea, WAIST SLEEVE 1ea, Single Hose 1ea, Doubl
08809315675208Main device 1ea, LEG SLEEVE Large 2ea, ARM SLEEVE 1ea, WAIST SLEEVE 1ea, Single Hose 1ea, Double
08809315675192Main device 1ea, LEG SLEEVE XXLarge 2ea, Double Hose 1ea, Recovery Bag 1ea [One set box]
08809315675185Main device 1ea, LEG SLEEVE XLarge 2ea, Double Hose 1ea, Recovery Bag 1ea [One set box]
08809315675178Main device 1ea, LEG SLEEVE Large 2ea, Double Hose 1ea, Recovery Bag 1ea [One set box]
18809315675168Main device 1ea, LEG SLEEVE XXLarge 2ea, ARM SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea [One s
18809315675151Main device 1ea, LEG SLEEVE XLarge 2ea, ARM SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea [One se
18809315675144Main device 1ea, LEG SLEEVE Large 2ea, ARM SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea [One set
08809315675130Main device 1ea, ARM SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea [One set box]
18809315675106Main device 1ea, LEG SLEEVE XXLarge 2ea, WAIST SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea, Dis
18809315675090Main device 1ea, LEG SLEEVE XLarge 2ea, WAIST SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea, Dist
18809315675083Main device 1ea, LEG SLEEVE Large 2ea, WAIST SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea, Distr
18809315675076Main device 1ea, LEG SLEEVE XXLarge 2ea, WAIST SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea [One
18809315675069Main device 1ea, LEG SLEEVE XLarge 2ea, WAIST SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea [One
18809315675052Main device 1ea, LEG SLEEVE Large 2ea, WAIST SLEEVE 1ea, Single Hose 1ea, Double Hose 1ea [One s
18809315675045Main device 1ea, LEG SLEEVE XXLarge 2ea, Single Hose 1ea, Double Hose 1ea [One set box]
18809315675038Main device 1ea, LEG SLEEVE XLarge 2ea, Single Hose 1ea, Double Hose 1ea [One set box]
18809315675021Main device 1ea, LEG SLEEVE Large 2ea, Single Hose 1ea, Double Hose 1ea [One set box]
18809315675014Main device 1ea, LEG SLEEVE XXLarge 2ea, Double Hose 1ea [One set box]
18809315675007Main device 1ea, LEG SLEEVE XLarge 2ea, Double Hose 1ea [One set box]
18809315674994Main device 1ea, LEG SLEEVE Large 2ea, Double Hose 1ea [One set box]
08809315674980Main device 1ea
18809315675120Main device 1ea, CENTER BODY SLEEVE 1ea, Center body extension zipper 2ea, Double Hose 1ea [One

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