ALLIVE

GUDID 08800051500021

Nu Eyne Co., Ltd.

Craniofacial analgesia electrical stimulator
Primary Device ID08800051500021
NIH Device Record Keyf434bb7b-f386-4c05-9d4c-0f46c9fcce68
Commercial Distribution StatusIn Commercial Distribution
Brand NameALLIVE
Version Model NumberALLIVE01
Company DUNS695649163
Company NameNu Eyne 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

Phone+821071220306
Emaildongseong.lee@nueyne.com
Phone+821071220306
Emaildongseong.lee@nueyne.com
Phone+821071220306
Emaildongseong.lee@nueyne.com
Phone+821071220306
Emaildongseong.lee@nueyne.com
Phone+821071220306
Emaildongseong.lee@nueyne.com
Phone+821071220306
Emaildongseong.lee@nueyne.com
Phone+821071220306
Emaildongseong.lee@nueyne.com
Phone+821071220306
Emaildongseong.lee@nueyne.com
Phone+821071220306
Emaildongseong.lee@nueyne.com
Phone+821071220306
Emaildongseong.lee@nueyne.com
Phone+821071220306
Emaildongseong.lee@nueyne.com
Phone+821071220306
Emaildongseong.lee@nueyne.com
Phone+821071220306
Emaildongseong.lee@nueyne.com
Phone+821071220306
Emaildongseong.lee@nueyne.com
Phone+821071220306
Emaildongseong.lee@nueyne.com
Phone+821071220306
Emaildongseong.lee@nueyne.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -5 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108800051500021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PCCStimulator, Nerve, Electrical, Transcutaneous, For Migraine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-30
Device Publish Date2021-03-22

Devices Manufactured by Nu Eyne Co., Ltd.

08800051500199 - ELEXIR2023-08-14
08800051500021 - ALLIVE2021-03-30
08800051500021 - ALLIVE2021-03-30

Trademark Results [ALLIVE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ALLIVE
ALLIVE
90499728 not registered Live/Pending
Wentian Precision Technology Co., Ltd.
2021-01-30

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