Address:2021 Airport Road,Conroe,TX,77301,US
Device Description : A hand-held device designed to regulate and direct a stream of pressurized fluid A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : No
Prescription Use : No
Device Description : An assembly of devices designed to evacuate fluid, tissue, gas, or other foreign An assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials from a body cavity or lumen by means of suction. It generally consists of a suction pump powered by compressed air or oxygen from a hospital's central gas system, tubing, plastic/glass collection container(s), a vacuum gauge, a regulator, an overflow trap, a moisture filter, and possibly a microbial filter. The pressurized gas enables the pump to create a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system can be used in a wide variety of hospital or other healthcare settings.
Device Class :
Duns Number: 938289980
Premarket Exempt : Yes
Prescription Use : No
Device Description : A hand-held device designed to regulate and direct a stream of pressurized fluid A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : No
Prescription Use : No
Device Description : An assembly of devices designed to evacuate fluid, tissue, gas, or other foreign An assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials from a body cavity or lumen by means of suction. It generally consists of a suction pump powered by compressed air or oxygen from a hospital's central gas system, tubing, plastic/glass collection container(s), a vacuum gauge, a regulator, an overflow trap, a moisture filter, and possibly a microbial filter. The pressurized gas enables the pump to create a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system can be used in a wide variety of hospital or other healthcare settings.
Device Class :
Duns Number: 938289980
Premarket Exempt : Yes
Prescription Use : No
Device Description : A sterile, porous device used in the arterial line of an extracorporeal circuit, A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : Yes
Prescription Use : No
Device Description : A sterile, porous device used in the arterial line of an extracorporeal circuit, A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : Yes
Prescription Use : No
Device Description : A sterile plastic device designed to join two or more tubes of a cardiopulmonary A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : Yes
Prescription Use : No
Device Description : A sterile plastic device designed to join two or more tubes of a cardiopulmonary A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : Yes
Prescription Use : No
Device Description : A sterile plastic device designed to join two or more tubes of a cardiopulmonary A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : Yes
Prescription Use : No
Device Description : A sterile plastic device designed to join two or more tubes of a cardiopulmonary A sterile plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : No
Prescription Use : No