ABL800 FLEX

GUDID 05700693938011

ABL800 FLEX with crea

Radiometer Medical ApS

Metabolic profile clinical chemistry analyser IVD, stationary, automated

• Primary Device ID: 05700693938011
• NIH Device Record Key: cb64116c-4b51-469e-b0d9-94cb756723bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABL800 FLEX
• Version Model Number: 393-801
• 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: false
• 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: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk
• Phone: +459999999999
• Email: radiometer@radiometer.dk

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 60 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 *Environmental specification 30-32 °C: Barometric pressure 80.0-106.7 kPa. Environmental specification 15-30 °C: Barometric pressure 70.0-106.7 kPa
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Environmental specification 30-32 °C: Barometric pressure 80.0-106.7 kPa. Environmental specification 15-30 °C: Barometric pressure 70.0-106.7 kPa
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Environmental specification 30-32 °C: Barometric pressure 80.0-106.7 kPa. Environmental specification 15-30 °C: Barometric pressure 70.0-106.7 kPa
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Environmental specification 30-32 °C: Barometric pressure 80.0-106.7 kPa. Environmental specification 15-30 °C: Barometric pressure 70.0-106.7 kPa
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Environmental specification 30-32 °C: Barometric pressure 80.0-106.7 kPa. Environmental specification 15-30 °C: Barometric pressure 70.0-106.7 kPa
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Environmental specification 30-32 °C: Barometric pressure 80.0-106.7 kPa. Environmental specification 15-30 °C: Barometric pressure 70.0-106.7 kPa
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Environmental specification 30-32 °C: Barometric pressure 80.0-106.7 kPa. Environmental specification 15-30 °C: Barometric pressure 70.0-106.7 kPa
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Environmental specification 30-32 °C: Barometric pressure 80.0-106.7 kPa. Environmental specification 15-30 °C: Barometric pressure 70.0-106.7 kPa
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Environmental specification 30-32 °C: Barometric pressure 80.0-106.7 kPa. Environmental specification 15-30 °C: Barometric pressure 70.0-106.7 kPa
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Environmental specification 30-32 °C: Barometric pressure 80.0-106.7 kPa. Environmental specification 15-30 °C: Barometric pressure 70.0-106.7 kPa
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Environmental specification 30-32 °C: Barometric pressure 80.0-106.7 kPa. Environmental specification 15-30 °C: Barometric pressure 70.0-106.7 kPa
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Environmental specification 30-32 °C: Barometric pressure 80.0-106.7 kPa. Environmental specification 15-30 °C: Barometric pressure 70.0-106.7 kPa
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Environmental specification 30-32 °C: Barometric pressure 80.0-106.7 kPa. Environmental specification 15-30 °C: Barometric pressure 70.0-106.7 kPa
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Environmental specification 30-32 °C: Barometric pressure 80.0-106.7 kPa. Environmental specification 15-30 °C: Barometric pressure 70.0-106.7 kPa
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Environmental specification 30-32 °C: Barometric pressure 80.0-106.7 kPa. Environmental specification 15-30 °C: Barometric pressure 70.0-106.7 kPa
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 107 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Environmental specification 30-32 °C: Barometric pressure 80.0-106.7 kPa. Environmental specification 15-30 °C: Barometric pressure 70.0-106.7 kPa
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 107 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	05700693938011 [Primary]

FDA Product Code

• CHL: ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

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: 2016-09-01

On-Brand Devices [ABL800 FLEX]

• 05700693938011: ABL800 FLEX with crea
• 05700693938004: ABL800 FLEX