Prismaflex 113081

GUDID 07332414105266

The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma E

GAMBRO AB

Haemodialysis system, institutional
Primary Device ID07332414105266
NIH Device Record Key2cfa9ab3-04e5-4056-907f-8020482f1817
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrismaflex
Version Model Number5.XX
Catalog Number113081
Company DUNS354021099
Company NameGAMBRO AB
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 Batchfalse
Serial Numbertrue
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+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Non-condensing humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Fragile handle with care, Do not stack
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -18 Degrees Celsius and 54 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 16 Degrees Celsius and 38 Degrees Celsius
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS107332414105266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDIDialyzer, high permeability with or without sealed dialysate system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-17

On-Brand Devices [Prismaflex]

07332414126766The Prismaflex control unit is a software controlled single patient device that performs Continu
07332414124236The Prismaflex control unit is a software controlled single patient device that performs Continu
07332414117702The Prismaflex control unit is a software controlled single patient device that performs Continu
07332414105266The Prismaflex control unit is a software controlled single patient device that performs Continu

Trademark Results [Prismaflex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRISMAFLEX
PRISMAFLEX
78861703 not registered Dead/Abandoned
Gambro Lundia AB
2006-04-14
PRISMAFLEX
PRISMAFLEX
78859340 not registered Dead/Abandoned
Gambro Lundia AB
2006-04-11
PRISMAFLEX
PRISMAFLEX
78513902 3102098 Live/Registered
Gambro Lundia AB
2004-11-09
PRISMAFLEX
PRISMAFLEX
78272350 2979008 Live/Registered
Gambro Lundia AB
2003-07-09
PRISMAFLEX
PRISMAFLEX
76290339 not registered Dead/Abandoned
RIGIFLEX INTERNATIONAL
2001-07-26
PRISMAFLEX
PRISMAFLEX
76115953 2698334 Live/Registered
Prismaflex USA, Inc
2000-08-24

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