The Venous Assist System

GUDID 28809315677695

Sequential compression pump with 2 Calf sleeves, 2 Hoses and Extension hoses

DAESUNG MAREF CO.,LTD.

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Primary Device ID28809315677695
NIH Device Record Key58a662b4-fa0e-475f-88fb-cca650f38a1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameThe Venous Assist System
Version Model NumberDVT-PRO
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 Batchtrue
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
GS118809315677698 [Primary]
GS128809315677695 [Package]
Contains: 18809315677698
Package: [8 Units]
In Commercial Distribution
GS138809315677692 [Package]
Contains: 18809315677698
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOWSleeve, Limb, Compressible

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 Date2016-09-06

On-Brand Devices [The Venous Assist System]

28809315678395sequential compression pump with 2 hoses
28809315677695Sequential compression pump with 2 Calf sleeves, 2 Hoses and Extension hoses
288093156777321 Chamber foot garment(One size)
08809315678384Sequential compression pump only
28809315677756Calf garment extension pad
288093156777183 Chamber calf garment(One size)
08809315677684Sequential compression pump only, The DVT-PRO device is a specialized intermittent pneumatic com

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