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 ID: 18809315675021
• NIH Device Record Key: 8989a1aa-9ade-4ab8-8f9e-15e14fbdff77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LX9max
• Version Model Number: LX9M200-BL-2
• Company DUNS: 688817949
• Company Name: DAESUNG MAREF CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809315675024 [Primary]
GS1	18809315675021 [Package]; Contains: 08809315675024; Package: Box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203498

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-22
• Device Publish Date: 2021-12-14

On-Brand Devices [LX9max]

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