Address:135 The West Mall, Unit 2,TORONTO Ontario,CA
Device Description : Smart Line TL Tube Luminometer is a stand-alone instrument with a built-in micr Smart Line TL Tube Luminometer is a stand-alone instrument with a built-in microprocessor software. Three softkeys and the <esc> key are all you need to operate the luminometer. Menus and parameters for functions that are not automated, are selected via these softkeys. The display shows the menu items, the actionsperformed and the user prompts.The luminometer includes an internal reading device for chip cards. Measurement protocols are saved on this chip card. During this procedure the user is prompted step by step to place the required tubes into the instrument for measurement. This ensures a high level of automation and standardization of the measurement process.
Device Class : 1
Duns Number: 248909939
Premarket Exempt : Yes
Prescription Use : No
Device Description : The EAA™ is a rapid in vitro diagnostic test that utilizes a specific monoclonal The EAA™ is a rapid in vitro diagnostic test that utilizes a specific monoclonal antibody to measure the endotoxin activity in EDTA whole blood specimens.
Device Class : 2
Duns Number: 248909939
Premarket Exempt : No
Prescription Use : No
Device Description : The EAA™ is a rapid in vitro diagnostic test that utilizes a specific monoclonal The EAA™ is a rapid in vitro diagnostic test that utilizes a specific monoclonal antibody to measure the endotoxin activity in EDTA whole blood specimens.
Device Class : 2
Duns Number: 248909939
Premarket Exempt : No
Prescription Use : No
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: 248909939
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 therapyin 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 to 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: 248909939
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: 248909939
Premarket Exempt : Yes
Prescription Use : Yes