Prismaflex 115269
GUDID 07332414117702
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| Primary Device ID | 07332414117702 |
| NIH Device Record Key | 833b4600-ff90-4645-867f-aa47d6b2d3f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prismaflex |
| Version Model Number | 7.XX |
| Catalog Number | 115269 |
| 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 | 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
Operating and Storage Conditions
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| 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 Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| 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 |
| 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 |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| 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 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332414117702 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-09 |
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 |
Trademark Results [Prismaflex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRISMAFLEX 78861703 not registered Dead/Abandoned |
Gambro Lundia AB 2006-04-14 |
 PRISMAFLEX 78859340 not registered Dead/Abandoned |
Gambro Lundia AB 2006-04-11 |
 PRISMAFLEX 78513902 3102098 Live/Registered |
Gambro Lundia AB 2004-11-09 |
 PRISMAFLEX 78272350 2979008 Live/Registered |
Gambro Lundia AB 2003-07-09 |
 PRISMAFLEX 76290339 not registered Dead/Abandoned |
RIGIFLEX INTERNATIONAL 2001-07-26 |
 PRISMAFLEX 76115953 2698334 Live/Registered |
Prismaflex USA, Inc 2000-08-24 |
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