POWER-Q1000

GUDID 48809277426021

Sequential venous compression system pump, A powered inflatable tube massager

WONJIN MULSAN CO.LTD

Sequential venous compression system pump Sequential venous compression system pump
Primary Device ID48809277426021
NIH Device Record Key73de95ae-3631-4bb2-87df-cdaaf92ead48
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOWER-Q1000
Version Model NumberWHF-314
Company DUNS690287912
Company NameWONJIN MULSAN 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

Customer Support Contacts

Phone1-516-376-2537
Emailwonjin@wonjininc.com
Phone1-516-376-2537
Emailwonjin@wonjininc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS118809277426020 [Package]
Package: carton box [1 Units]
In Commercial Distribution
GS128809277426027 [Package]
Package: carton box [2 Units]
In Commercial Distribution
GS138809277426024 [Package]
Package: carton box [4 Units]
In Commercial Distribution
GS148809277426021 [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 Date2016-08-19

On-Brand Devices [POWER-Q1000]

48809277426021Sequential venous compression system pump, A powered inflatable tube massager
08809277420014Sequential venous compression system pump, A powered inflatable tube massager

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