Pure-Vu PV-LUFK-001

GUDID 05060513700038

(1) Loading fixture & (1) Unloading fixture with sealing plugs

MOTUS GI MEDICAL TECHNOLOGIES LTD

Colonic lavage system, powered-flow
Primary Device ID05060513700038
NIH Device Record Key327eb172-ba60-4a71-85db-358910d94c18
Commercial Distribution StatusIn Commercial Distribution
Brand NamePure-Vu
Version Model NumberPV-LUFK-001
Catalog NumberPV-LUFK-001
Company DUNS532775983
Company NameMOTUS GI MEDICAL TECHNOLOGIES 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-438-9996
Emailcustomer@motusgi.com
Phone888-438-9996
Emailcustomer@motusgi.com
Phone888-438-9996
Emailcustomer@motusgi.com
Phone888-438-9996
Emailcustomer@motusgi.com
Phone888-438-9996
Emailcustomer@motusgi.com
Phone888-438-9996
Emailcustomer@motusgi.com
Phone888-438-9996
Emailcustomer@motusgi.com
Phone888-438-9996
Emailcustomer@motusgi.com
Phone888-438-9996
Emailcustomer@motusgi.com
Phone888-438-9996
Emailcustomer@motusgi.com
Phone888-438-9996
Emailcustomer@motusgi.com
Phone888-438-9996
Emailcustomer@motusgi.com
Phone888-438-9996
Emailcustomer@motusgi.com
Phone888-438-9996
Emailcustomer@motusgi.com
Phone888-438-9996
Emailcustomer@motusgi.com
Phone888-438-9996
Emailcustomer@motusgi.com
Phone888-438-9996
Emailcustomer@motusgi.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0 KiloPascal and 81 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0 KiloPascal and 81 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0 KiloPascal and 81 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0 KiloPascal and 81 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0 KiloPascal and 81 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0 KiloPascal and 81 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0 KiloPascal and 81 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0 KiloPascal and 81 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0 KiloPascal and 81 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0 KiloPascal and 81 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0 KiloPascal and 81 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0 KiloPascal and 81 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0 KiloPascal and 81 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0 KiloPascal and 81 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0 KiloPascal and 81 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0 KiloPascal and 81 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 0 KiloPascal and 81 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS105060513700038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDFColonoscope And Accessories, Flexible/Rigid

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 Date2017-01-03

On-Brand Devices [Pure-Vu]

05060513700120(1) Slim Oversleeve individually packaged
05060513700113(5) Slim Oversleeves individually packaged
05060513700076(1) Workstation connector individually packaged
05060513700083(1) Workstation connector
05060513700052(1) Oversleeve individually packaged
05060513700090(1) Oversleeve
05060513700038(1) Loading fixture & (1) Unloading fixture with sealing plugs
05060513700021(1) Unloading fixture with sealing plug
05060513700014(1) Loading fixture with sealing plug
05060513700007(1) Workstation with foot pedal

Trademark Results [Pure-Vu]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PURE-VU
PURE-VU
87910044 not registered Live/Pending
Stom Pharma Inc.
2018-05-07
PURE-VU
PURE-VU
86788107 5277012 Live/Registered
Motus GI, Inc.
2015-10-14
PURE-VU
PURE-VU
76532034 not registered Dead/Abandoned
ETHYLENE, LLC
2003-07-21

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