ABL90 FLEX PLUS Analyzer 393-092

GUDID 05700693930923

ABL90 FLEX PLUS, Analyzer without casettes, cables, manuals etc.

Radiometer Medical ApS

Metabolic profile clinical chemistry analyser IVD, portable, automated

• Primary Device ID: 05700693930923
• NIH Device Record Key: 788523a7-263f-413c-8900-4ad2e6a84dd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABL90 FLEX PLUS Analyzer
• Version Model Number: 393-092
• Catalog Number: 393-092
• Company DUNS: 308667539
• Company Name: Radiometer Medical ApS
• 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: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk
• Phone: +45999999999
• Email: radiometer@radiometer.dk

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 107 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700693930923 [Primary]

FDA Product Code

• MQM: BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM

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: 2017-02-15

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