Compressible Limb Therapy System(LX7(V7))

GUDID 38809315677982

4Chamber Center-body extension zipper (one size)

DAESUNG MAREF CO.,LTD.

Pneumatic massager
Primary Device ID38809315677982
NIH Device Record Keyefdf6942-5445-49fd-80fa-99b979b80a03
Commercial Distribution Discontinuation2017-12-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCompressible Limb Therapy System(LX7(V7))
Version Model NumberACg0433
Company DUNS688817949
Company NameDAESUNG MAREF CO.,LTD.
Device Count2
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 Batchtrue
Serial Numberfalse
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
GS108809315677974 [Unit of Use]
GS138809315677982 [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 Number3
Public Version Date2018-07-06
Device Publish Date2017-12-11

On-Brand Devices [Compressible Limb Therapy System(LX7(V7))]

488093156781394 Chamber Overlapping Half-leg (Medium Wide) sleeve with Hose
488093156781224 Chamber Overlapping Half-leg (Medium) sleeve with Hose
388093156781324 Chamber Overlapping Half-leg (Medium Wide) sleeve with Hose
388093156781254 Chamber Overlapping Half-leg (Medium) sleeve with Hose
388093156779824Chamber Center-body extension zipper (one size)
388093156779064Chamber one-touch center-body sleeve (one size) with 2 extension zipper

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