PRISMAFLEX 955792

GUDID 07332414126766

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 Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional Haemodialysis system, institutional

• Primary Device ID: 07332414126766
• NIH Device Record Key: 8ccdc4cf-ca3a-4b6b-8b6c-07424bbcf807
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRISMAFLEX
• Version Model Number: 7.21
• Catalog Number: 955792
• Company DUNS: 354021099
• Company Name: GAMBRO AB
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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: +1(888)229-0001
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
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• Phone: +1(888)229-0001
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• Phone: +1(888)229-0001
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• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(888)229-0001
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• Phone: +1(888)229-0001
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• Phone: +1(888)229-0001
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(888)229-0001
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM
• Phone: +1(888)229-0001
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Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry, Fragile Handle with care, Do not stack; Non-condesing humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332414126766 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131516

FDA Product Code

• KDI: Dialyzer, high permeability with or without sealed dialysate system

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-28

On-Brand Devices [PRISMAFLEX]

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