SYSTEM EBIKE L EXT TRMNL 120V US

GUDID 04059358000190

ergoline GmbH

Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer
Primary Device ID04059358000190
NIH Device Record Keyf5aa2bbf-835c-4dc5-b9cd-7fabee784374
Commercial Distribution StatusIn Commercial Distribution
Brand NameSYSTEM EBIKE L EXT TRMNL 120V US
Version Model Number2017911-115
Company DUNS314403192
Company Nameergoline GmbH
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Weight160 Kilogram
Height160 Centimeter
Width80 Centimeter
Length220 Centimeter
Weight160 Kilogram
Height160 Centimeter
Width80 Centimeter
Length220 Centimeter
Weight160 Kilogram
Height160 Centimeter
Width80 Centimeter
Length220 Centimeter
Weight160 Kilogram
Height160 Centimeter
Width80 Centimeter
Length220 Centimeter
Weight160 Kilogram
Height160 Centimeter
Width80 Centimeter
Length220 Centimeter
Weight160 Kilogram
Height160 Centimeter
Width80 Centimeter
Length220 Centimeter
Weight160 Kilogram
Height160 Centimeter
Width80 Centimeter
Length220 Centimeter
Weight160 Kilogram
Height160 Centimeter
Width80 Centimeter
Length220 Centimeter
Weight160 Kilogram
Height160 Centimeter
Width80 Centimeter
Length220 Centimeter
Weight160 Kilogram
Height160 Centimeter
Width80 Centimeter
Length220 Centimeter
Weight160 Kilogram
Height160 Centimeter
Width80 Centimeter
Length220 Centimeter
Weight160 Kilogram
Height160 Centimeter
Width80 Centimeter
Length220 Centimeter
Weight160 Kilogram
Height160 Centimeter
Width80 Centimeter
Length220 Centimeter

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104059358000190 [Primary]

FDA Product Code

ISDExerciser, Measuring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

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