Compressible Limb Therapy System

GUDID 28809315678364

Sequential compression pump with 1 double hose and 1 single hose.

DAESUNG MAREF CO.,LTD.

Pneumatic massager Pneumatic massager
Primary Device ID28809315678364
NIH Device Record Key79c1706e-3107-46a4-bf69-6b3edc2e792a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCompressible Limb Therapy System
Version Model NumberLX7(V7)
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
GS118809315678367 [Primary]
GS128809315678364 [Package]
Contains: 18809315678367
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 Date2018-07-20
Device Publish Date2018-06-19

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.

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