ABL800 FLEX

GUDID 05700693938004

ABL800 FLEX

Radiometer Medical ApS

Metabolic profile clinical chemistry analyser IVD, stationary, automated
Primary Device ID05700693938004
NIH Device Record Key65bb0ce9-1fe6-467f-b2e9-47125ae2c560
Commercial Distribution StatusIn Commercial Distribution
Brand NameABL800 FLEX
Version Model Number393-800
Company DUNS308667539
Company NameRadiometer Medical ApS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 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 Atmospheric PressureBetween 60 KiloPascal and 107 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 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 HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 107 KiloPascal
Special Storage Condition, SpecifyBetween 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 HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 107 KiloPascal
Special Storage Condition, SpecifyBetween 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 HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 107 KiloPascal
Special Storage Condition, SpecifyBetween 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 HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 107 KiloPascal
Special Storage Condition, SpecifyBetween 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 HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 107 KiloPascal
Special Storage Condition, SpecifyBetween 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 HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 107 KiloPascal
Special Storage Condition, SpecifyBetween 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 HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 107 KiloPascal
Special Storage Condition, SpecifyBetween 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 HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 107 KiloPascal
Special Storage Condition, SpecifyBetween 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 HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 107 KiloPascal
Special Storage Condition, SpecifyBetween 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 HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 107 KiloPascal
Special Storage Condition, SpecifyBetween 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 HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 107 KiloPascal
Special Storage Condition, SpecifyBetween 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 HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 107 KiloPascal
Special Storage Condition, SpecifyBetween 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 HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 107 KiloPascal
Special Storage Condition, SpecifyBetween 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 HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 107 KiloPascal
Special Storage Condition, SpecifyBetween 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 HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Handling Environment Atmospheric PressureBetween 60 KiloPascal and 107 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS105700693938004 [Primary]

FDA Product Code

CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-01

On-Brand Devices [ABL800 FLEX]

05700693938011ABL800 FLEX with crea
05700693938004ABL800 FLEX

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