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 Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD Metabolic profile clinical chemistry analyser IVD

• 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

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

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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