Seat Ergometer ergoselect 150 P child

GUDID 04059358002699

ergoline GmbH

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Primary Device ID04059358002699
NIH Device Record Key7d3650e6-95aa-468d-8424-e79fe8b7ff9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSeat Ergometer ergoselect 150 P child
Version Model Number1612170
Company DUNS314403192
Company Nameergoline GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Height135 Centimeter
Width42 Centimeter
Length90 Centimeter
Weight83 Kilogram
Height135 Centimeter
Width42 Centimeter
Length90 Centimeter
Weight83 Kilogram
Height135 Centimeter
Width42 Centimeter
Length90 Centimeter
Weight83 Kilogram
Height135 Centimeter
Width42 Centimeter
Length90 Centimeter
Weight83 Kilogram
Height135 Centimeter
Width42 Centimeter
Length90 Centimeter
Weight83 Kilogram
Height135 Centimeter
Width42 Centimeter
Length90 Centimeter
Weight83 Kilogram
Height135 Centimeter
Width42 Centimeter
Length90 Centimeter
Weight83 Kilogram
Height135 Centimeter
Width42 Centimeter
Length90 Centimeter
Weight83 Kilogram
Height135 Centimeter
Width42 Centimeter
Length90 Centimeter
Weight83 Kilogram
Height135 Centimeter
Width42 Centimeter
Length90 Centimeter
Weight83 Kilogram
Height135 Centimeter
Width42 Centimeter
Length90 Centimeter
Weight83 Kilogram
Height135 Centimeter
Width42 Centimeter
Length90 Centimeter
Weight83 Kilogram
Height135 Centimeter
Width42 Centimeter
Length90 Centimeter
Weight83 Kilogram
Height135 Centimeter
Width42 Centimeter
Length90 Centimeter
Weight83 Kilogram
Height135 Centimeter
Width42 Centimeter
Length90 Centimeter
Weight83 Kilogram
Height135 Centimeter
Width42 Centimeter
Length90 Centimeter
Weight83 Kilogram
Height135 Centimeter
Width42 Centimeter
Length90 Centimeter
Weight83 Kilogram
Height135 Centimeter
Width42 Centimeter
Length90 Centimeter
Weight83 Kilogram

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
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
GS104059358002699 [Primary]

FDA Product Code

ISDExerciser, Measuring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-18
Device Publish Date2023-05-10

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