Couch Ergometer ergoselect 1200 EL 230V P BP

GUDID 04059358000374

ergoline GmbH

Bicycle ergometer
Primary Device ID04059358000374
NIH Device Record Keyd2f11803-4c33-47f3-9f0d-83e98233c2bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCouch Ergometer ergoselect 1200 EL 230V P BP
Version Model Number1616020
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

Weight140 Kilogram
Height180 Centimeter
Width90 Centimeter
Length220 Centimeter
Weight140 Kilogram
Height180 Centimeter
Width90 Centimeter
Length220 Centimeter
Weight140 Kilogram
Height180 Centimeter
Width90 Centimeter
Length220 Centimeter
Weight140 Kilogram
Height180 Centimeter
Width90 Centimeter
Length220 Centimeter
Weight140 Kilogram
Height180 Centimeter
Width90 Centimeter
Length220 Centimeter
Weight140 Kilogram
Height180 Centimeter
Width90 Centimeter
Length220 Centimeter
Weight140 Kilogram
Height180 Centimeter
Width90 Centimeter
Length220 Centimeter
Weight140 Kilogram
Height180 Centimeter
Width90 Centimeter
Length220 Centimeter
Weight140 Kilogram
Height180 Centimeter
Width90 Centimeter
Length220 Centimeter
Weight140 Kilogram
Height180 Centimeter
Width90 Centimeter
Length220 Centimeter
Weight140 Kilogram
Height180 Centimeter
Width90 Centimeter
Length220 Centimeter
Weight140 Kilogram
Height180 Centimeter
Width90 Centimeter
Length220 Centimeter
Weight140 Kilogram
Height180 Centimeter
Width90 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
GS104059358000374 [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

Devices Manufactured by ergoline GmbH

04059358002224 - optibike basic2023-05-22
04059358001746 - ers2 1CH Telemetry Transmitter2023-05-18
04059358001753 - ers2 ECG Receiver2023-05-18
04059358001760 - ers2 1CH ECG Adapter2023-05-18
04059358001777 - ers2 1CH ECG Transmitter Set (Adapter)2023-05-18
04059358001821 - ergoselect 12023-05-18
04059358001838 - ers2 Basic Software2023-05-18
04059358002095 - ers2 1CH ECG Adapter US Set 5 pcs.2023-05-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.