Seat Ergometer ergoselect 100 P

GUDID 04059358000275

ergoline GmbH

Bicycle ergometer

Primary Device ID	04059358000275
NIH Device Record Key	d5cd24b9-8ab5-48eb-8529-82de956ae8d3
Commercial Distribution Status	In Commercial Distribution
Brand Name	Seat Ergometer ergoselect 100 P
Version Model Number	1611010
Company DUNS	314403192
Company Name	ergoline GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Dimensions

Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter
Weight	61 Kilogram
Height	135 Centimeter
Width	46 Centimeter
Length	90 Centimeter

Operating and Storage Conditions

Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04059358000275 [Primary]

FDA Product Code

ISD	Exerciser, Measuring

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2016-09-24

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