Prismaflex 955542
GUDID 07332414124236
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 ID | 07332414124236 |
| NIH Device Record Key | 30ac237e-86be-4da0-ad43-95276984d308 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prismaflex |
| Version Model Number | 7.20 |
| Catalog Number | 955542 |
| 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
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Fragile handle with care, Do not stack |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| 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 Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| 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 Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| 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 Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| 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 Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| 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 Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| 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 Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| 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 Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| 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 Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| 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 Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 38 Degrees Celsius |
| 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 Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Storage Environment Temperature | Between -18 Degrees Celsius and 54 Degrees Celsius |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 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 |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 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 |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 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 |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 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 |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 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 |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 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 |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 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 |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 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 |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 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 |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 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 |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 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 |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 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 |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 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 |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 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 |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 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 |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 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 |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Non-condensing humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 100 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 |
| 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 |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332414124236 [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 | 2017-11-24 |
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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