Address:2021 Airport Road,Conroe,TX,77301,US
Device Description : A sterile device designed to facilitate/regulate the delivery of cardioplegic so A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : Yes
Prescription Use : No
Device Description : A sterile device designed to facilitate/regulate the delivery of cardioplegic so A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : No
Prescription Use : No
Device Description : A sterile device designed to facilitate/regulate the delivery of cardioplegic so A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : No
Prescription Use : No
Device Description : A sterile device designed to facilitate/regulate the delivery of cardioplegic so A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : No
Prescription Use : No
Device Description : 1/2 TUBING TO FIT OVER THE CORONARY PERFUSION OUTLET PORT OF AN OXYGENATOR, TO 1/2 TUBING TO FIT OVER THE CORONARY PERFUSION OUTLET PORT OF AN OXYGENATOR, TO SECURELY SEAL OFF THE PORT, THUS REDUCING THE POSSIBLITY OF THE PORT BEING INADVERTENTLY OPENED DUTING THE HEMOPERFUSION PROCEEDURE.
Device Class :
Duns Number: 938289980
Premarket Exempt : Yes
Prescription Use : No
Device Description : 1/2" TUBING TO FIT OVER THE CORONARY PERFUSION OULTET PORT OF AN OXYGENATOR, TO 1/2" TUBING TO FIT OVER THE CORONARY PERFUSION OULTET PORT OF AN OXYGENATOR, TO SECURELY SEAL OFF THE PORT, THUS REDUCING THE POSSIBILITY OF THE PORT BEING INADVERTENTLY OPENED DURING THE HEMOPERFUSION PROCEDURE.
Device Class :
Duns Number: 938289980
Premarket Exempt : Yes
Prescription Use : No
Device Description : A small, sterile device intended to connect an intravenous (IV) fluid bag or blo A small, sterile device intended to connect an intravenous (IV) fluid bag or blood bag to a fluid line to administer fluid to a patient. It consists of a plastic hollow spike at one end intended to be inserted into the IV bag port, a connector at the other end to attach to the IV line (typically via a drip chamber) and may include an additional administration port (i.e., Y-site device). It does not include a built-in drip chamber. This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : Yes
Prescription Use : No
Device Description : A small, sterile device intended to connect an intravenous (IV) fluid bag or blo A small, sterile device intended to connect an intravenous (IV) fluid bag or blood bag to a fluid line to administer fluid to a patient. It consists of a plastic hollow spike at one end intended to be inserted into the IV bag port, a connector at the other end to attach to the IV line (typically via a drip chamber) and may include an additional administration port (i.e., Y-site device). It does not include a built-in drip chamber. This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : Yes
Prescription Use : No
Device Description : A sterile device designed to facilitate/regulate the delivery of cardioplegic so A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : No
Prescription Use : No
Device Description : A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of priming fluids during the priming of the extracorporeal circuit of a cardiopulmonary bypass system. It is a noninvasive product in the form of a tube or tubing used to channel the fluids (i.e., primer/blood) to facilitate priming of the extracorporeal circuit and connection of the cardiopulmonary bypass system (heart/lung machine) to the patient. It is typically a moulded plastic tube with hard plastic spike at the distal end that connects to the bag or container of primer solution, a connector at the proximal end, and a central pinch clamp. This is a single-use device.
Device Class :
Duns Number: 938289980
Premarket Exempt : No
Prescription Use : No