ergocar basic

GUDID 04059358002484

ergoline GmbH

Electromechanical device/system transport trolley

Primary Device ID	04059358002484
NIH Device Record Key	2ae61e90-c3aa-4fdd-80dd-f70c1dbca366
Commercial Distribution Status	In Commercial Distribution
Brand Name	ergocar basic
Version Model Number	171001
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	false
OTC Over-The-Counter	false

Device Dimensions

Width	60 Centimeter
Length	60 Centimeter
Height	90 Centimeter
Weight	45 Kilogram
Width	60 Centimeter
Length	60 Centimeter
Height	90 Centimeter
Weight	45 Kilogram
Width	60 Centimeter
Length	60 Centimeter
Height	90 Centimeter
Weight	45 Kilogram
Width	60 Centimeter
Length	60 Centimeter
Height	90 Centimeter
Weight	45 Kilogram
Width	60 Centimeter
Length	60 Centimeter
Height	90 Centimeter
Weight	45 Kilogram
Width	60 Centimeter
Length	60 Centimeter
Height	90 Centimeter
Weight	45 Kilogram
Width	60 Centimeter
Length	60 Centimeter
Height	90 Centimeter
Weight	45 Kilogram
Width	60 Centimeter
Length	60 Centimeter
Height	90 Centimeter
Weight	45 Kilogram
Width	60 Centimeter
Length	60 Centimeter
Height	90 Centimeter
Weight	45 Kilogram
Width	60 Centimeter
Length	60 Centimeter
Height	90 Centimeter
Weight	45 Kilogram
Width	60 Centimeter
Length	60 Centimeter
Height	90 Centimeter
Weight	45 Kilogram
Width	60 Centimeter
Length	60 Centimeter
Height	90 Centimeter
Weight	45 Kilogram
Width	60 Centimeter
Length	60 Centimeter
Height	90 Centimeter
Weight	45 Kilogram
Width	60 Centimeter
Length	60 Centimeter
Height	90 Centimeter
Weight	45 Kilogram
Width	60 Centimeter
Length	60 Centimeter
Height	90 Centimeter
Weight	45 Kilogram
Width	60 Centimeter
Length	60 Centimeter
Height	90 Centimeter
Weight	45 Kilogram
Width	60 Centimeter
Length	60 Centimeter
Height	90 Centimeter
Weight	45 Kilogram
Width	60 Centimeter
Length	60 Centimeter
Height	90 Centimeter
Weight	45 Kilogram

Operating and Storage Conditions

Handling Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04059358002484 [Primary]

FDA Product Code

FWZ	Operating Room Accessories Table Tray

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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