ergoselect 12

GUDID 04059358002231

ergoline GmbH

Bicycle ergometer

Primary Device ID	04059358002231
NIH Device Record Key	26aa1999-5cff-4dfc-be6d-0ff5e2f9d364
Commercial Distribution Status	In Commercial Distribution
Brand Name	ergoselect 12
Version Model Number	192001
Company DUNS	314403192
Company Name	ergoline GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	true
OTC Over-The-Counter	false

Device Dimensions

Length	220 Centimeter
Width	90 Centimeter
Height	180 Centimeter
Weight	255 Kilogram
Length	220 Centimeter
Width	90 Centimeter
Height	180 Centimeter
Weight	255 Kilogram
Length	220 Centimeter
Width	90 Centimeter
Height	180 Centimeter
Weight	255 Kilogram
Length	220 Centimeter
Width	90 Centimeter
Height	180 Centimeter
Weight	255 Kilogram
Length	220 Centimeter
Width	90 Centimeter
Height	180 Centimeter
Weight	255 Kilogram
Length	220 Centimeter
Width	90 Centimeter
Height	180 Centimeter
Weight	255 Kilogram
Length	220 Centimeter
Width	90 Centimeter
Height	180 Centimeter
Weight	255 Kilogram
Length	220 Centimeter
Width	90 Centimeter
Height	180 Centimeter
Weight	255 Kilogram
Length	220 Centimeter
Width	90 Centimeter
Height	180 Centimeter
Weight	255 Kilogram
Length	220 Centimeter
Width	90 Centimeter
Height	180 Centimeter
Weight	255 Kilogram
Length	220 Centimeter
Width	90 Centimeter
Height	180 Centimeter
Weight	255 Kilogram
Length	220 Centimeter
Width	90 Centimeter
Height	180 Centimeter
Weight	255 Kilogram
Length	220 Centimeter
Width	90 Centimeter
Height	180 Centimeter
Weight	255 Kilogram
Length	220 Centimeter
Width	90 Centimeter
Height	180 Centimeter
Weight	255 Kilogram
Length	220 Centimeter
Width	90 Centimeter
Height	180 Centimeter
Weight	255 Kilogram
Length	220 Centimeter
Width	90 Centimeter
Height	180 Centimeter
Weight	255 Kilogram
Length	220 Centimeter
Width	90 Centimeter
Height	180 Centimeter
Weight	255 Kilogram
Length	220 Centimeter
Width	90 Centimeter
Height	180 Centimeter
Weight	255 Kilogram

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04059358002231 [Primary]

FDA Product Code

ISD	Exerciser, Measuring

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-05-18
Device Publish Date	2023-05-10

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