SYSTEM EBIKE BASIC US & BP

GUDID 04059358000145

ergoline GmbH

Bicycle ergometer

• Primary Device ID: 04059358000145
• NIH Device Record Key: 322a1c7b-73cf-4d69-bc72-b589fd5a28c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYSTEM EBIKE BASIC US & BP
• Version Model Number: 2017911-104
• 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: 78 Kilogram
• Height: 145 Centimeter
• Width: 60 Centimeter
• Length: 108 Centimeter
• Weight: 78 Kilogram
• Height: 145 Centimeter
• Width: 60 Centimeter
• Length: 108 Centimeter
• Weight: 78 Kilogram
• Height: 145 Centimeter
• Width: 60 Centimeter
• Length: 108 Centimeter
• Weight: 78 Kilogram
• Height: 145 Centimeter
• Width: 60 Centimeter
• Length: 108 Centimeter
• Weight: 78 Kilogram
• Height: 145 Centimeter
• Width: 60 Centimeter
• Length: 108 Centimeter
• Weight: 78 Kilogram
• Height: 145 Centimeter
• Width: 60 Centimeter
• Length: 108 Centimeter
• Weight: 78 Kilogram
• Height: 145 Centimeter
• Width: 60 Centimeter
• Length: 108 Centimeter
• Weight: 78 Kilogram
• Height: 145 Centimeter
• Width: 60 Centimeter
• Length: 108 Centimeter
• Weight: 78 Kilogram
• Height: 145 Centimeter
• Width: 60 Centimeter
• Length: 108 Centimeter
• Weight: 78 Kilogram
• Height: 145 Centimeter
• Width: 60 Centimeter
• Length: 108 Centimeter
• Weight: 78 Kilogram
• Height: 145 Centimeter
• Width: 60 Centimeter
• Length: 108 Centimeter
• Weight: 78 Kilogram
• Height: 145 Centimeter
• Width: 60 Centimeter
• Length: 108 Centimeter
• Weight: 78 Kilogram
• Height: 145 Centimeter
• Width: 60 Centimeter
• Length: 108 Centimeter
• Weight: 78 Kilogram
• Height: 145 Centimeter
• Width: 60 Centimeter
• Length: 108 Centimeter
• Weight: 78 Kilogram
• Height: 145 Centimeter
• Width: 60 Centimeter
• Length: 108 Centimeter
• Weight: 78 Kilogram
• Height: 145 Centimeter
• Width: 60 Centimeter
• Length: 108 Centimeter
• Weight: 78 Kilogram
• Height: 145 Centimeter
• Width: 60 Centimeter
• Length: 108 Centimeter
• Weight: 78 Kilogram
• Height: 145 Centimeter
• Width: 60 Centimeter
• Length: 108 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04059358000145 [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

Devices Manufactured by ergoline GmbH

• 04059358002224 - optibike basic: 2023-05-22
• 04059358001746 - ers2 1CH Telemetry Transmitter: 2023-05-18
• 04059358001753 - ers2 ECG Receiver: 2023-05-18
• 04059358001760 - ers2 1CH ECG Adapter: 2023-05-18
• 04059358001777 - ers2 1CH ECG Transmitter Set (Adapter): 2023-05-18
• 04059358001821 - ergoselect 1: 2023-05-18
• 04059358001838 - ers2 Basic Software: 2023-05-18
• 04059358002095 - ers2 1CH ECG Adapter US Set 5 pcs.: 2023-05-18