Compressible Limb Therapy System

GUDID 08809315678957

Sequential compression pump only.

DAESUNG MAREF CO.,LTD.

Sequential venous compression system inflator
Primary Device ID08809315678957
NIH Device Record Key37dae65a-a979-44a2-aa76-d5f7da470945
Commercial Distribution StatusIn Commercial Distribution
Brand NameCompressible Limb Therapy System
Version Model NumberMK300L
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809315678957 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-09-19
Device Publish Date2016-10-24

On-Brand Devices [Compressible Limb Therapy System]

18809315678985Compressible Limb Therapy System pump with 1arm sleeve, 2extension zipper and 4single hoses.
18809315678978Compressible Limb Therapy System pump with 2leg sleeves(Extra large), 1waist sleeve, 1arm sleeve
18809315678961Compressible Limb Therapy System pump with 2leg sleeves(Large), 1waist sleeve, 1arm sleeve and 4
28809315678944LX7 set : Sequential Compression Pump with 2 Leg Sleeves(XXL Size), 1 Double Hose
28809315678937LX7 set : Sequential Compression Pump with 2 Leg Sleeves(XL Size), 1 Double Hose
28809315678920LX7 set : Sequential Compression Pump with 2 Leg Sleeves(L Size), 1 Double Hose
28809315678364Sequential compression pump with 1 double hose and 1 single hose.
28809315678357Sequential compression pump with 1 double hose
28809315678159Sequential compression pump with 2 leg sleeve (M), 1 double hose and 1 single hose.
28809315677824Sequential compression pump with 2 leg sleeve (XL), 1 double hose and 1 single hose.
18809315677810Sequential compression pump with 2 leg sleeve (L), 1 double hose and 1 single hose.
08809315678957Sequential compression pump only.

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