Address:135 The West Mall, Unit 2,Toronto Ontario,CA
Device Description : The DIMI RRT Cassette is provided sterile, single use only, and has a non-toxic, The DIMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Device Class : 2
Duns Number: 203940515
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The DIMI RRT System is a software controlled device that performs the following The DIMI RRT System is a software controlled device that performs the following functions: - Primes the disposable cassette automatically,- Pumps blood through the blood flow path of the disposable cassette,- Delivers anticoagulant into the blood flow path,- Pumps sterile infusion solutions into the blood flow path of the disposable according to therapy in use,- Pumps sterile dialysate into the fluid compartment of the filter in RRT therapies,- Controls the patient fluid removal or plasma loss according to the therapy in use,- Monitors the system and alerts the operator of abnormal situations through alarms.The DIMI RRT System has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the cassette tubing set.
Device Class : 2
Duns Number: 203940515
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The SAMI RRT Unit is a software controlled device that performs the following fu The SAMI RRT Unit is a software controlled device that performs the following functions: - Primes the disposable cassette automatically,- Pumps blood through the blood flow path of the disposable cassette,- Delivers anticoagulant into the blood flow path,- Pumps sterile infusion solutions into the blood flow path of the disposable according to therapy in use,- Pumps sterile dialysate into the fluid compartment of the filter in RRT therapies,- Controls the patient fluid removal or plasma loss according to the therapy in use,- Monitors the system and alerts the operator of abnormal situations through alarms.The SAMI RRT Unit has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the cassette tubing set.
Device Class : 2
Duns Number: 203940515
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Device Class : 2
Duns Number: 203940515
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Device Class : 2
Duns Number: 203940515
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The SAMI RRT Unit is a software controlled device that performs the following fu The SAMI RRT Unit is a software controlled device that performs the following functions: - Primes the disposable cassette automatically,- Pumps blood through the blood flow path of the disposable cassette,- Delivers anticoagulant into the blood flow path,- Pumps sterile infusion solutions into the blood flow path of the disposable according to therapy in use,- Pumps sterile dialysate into the fluid compartment of the filter in RRT therapies,- Controls the patient fluid removal or plasma loss according to the therapy in use,- Monitors the system and alerts the operator of abnormal situations through alarms.The SAMI RRT Unit has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the cassette tubing set.
Device Class : 2
Duns Number: 203940515
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Device Class : 2
Duns Number: 203940515
Premarket Exempt : Yes
Prescription Use : Yes