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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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.
NOVOSCI CORP.
301021-000
In Commercial Distribution

  • B0663010210006 ()
  • B0663010210000 ()
  • B0663010210005 ()
  • B0663010210004 ()
  • B0663010210003 ()
301021-000

  • Cardioplegia solution administration adaptor
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.
NOVOSCI CORP.
301018-000
In Commercial Distribution

  • B0663010180006 ()
  • B0663010180000 ()
  • B0663010180005 ()
  • B0663010180004 ()
  • B0663010180003 ()
301018-000

  • Cardioplegia solution administration adaptor
1/4" 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.
NOVOSCI CORP.
301015-000
Not in Commercial Distribution

  • B0663010150000 ()
  • B0663010150007 ()
  • B0663010150006 ()
  • B0663010150005 ()
  • B0663010150003 ()
301015-000

  • Stopcock
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.
NOVOSCI CORP.
301012-000
In Commercial Distribution

  • B0663010120007 ()
  • B0663010120000 ()
  • B0663010120006 ()
  • B0663010120005 ()
  • B0663010120003 ()
301012-000

  • Cardiopulmonary bypass system priming set
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.
NOVOSCI CORP.
301011-000
In Commercial Distribution

  • B0663010110000 ()
  • B0663010110003 ()
  • B0663010110005 ()
  • B0663010110007 ()
  • B0663010110006 ()
301011-000

  • Cardiopulmonary bypass system priming set
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.
NOVOSCI CORP.
301010-000
In Commercial Distribution

  • B0663010100000 ()
  • B0663010100003 ()
  • B0663010100005 ()
  • B0663010100007 ()
  • B0663010100006 ()
301010-000

  • Non-ISO80369-standardized small-bore linear connector, single-use
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.
NOVOSCI CORP.
301009-000
In Commercial Distribution

  • B0663010090007 ()
  • B0663010090000 ()
  • B0663010090006 ()
  • B0663010090005 ()
  • B0663010090003 ()
301009-000

  • Non-ISO80369-standardized small-bore linear connector, single-use
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.
NOVOSCI CORP.
301001-000
In Commercial Distribution

  • B0663010010000 ()
  • B0663010010005 ()
  • B0663010010003 ()
  • B0663010010007 ()
  • B0663010010006 ()
301001-000

  • Cardiopulmonary bypass system filter, arterial blood line
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.
NOVOSCI CORP.
201301-000
In Commercial Distribution

  • B0662013010006 ()
  • B0662013010000 ()
  • B0662013010005 ()
  • B0662013010004 ()
  • B0662013010003 ()
201301-000

  • General-purpose surgical suction system, vacuum
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.
NOVOSCI CORP.
201280-000
In Commercial Distribution

  • B0662012800006 ()
  • B0662012800000 ()
  • B0662012800005 ()
  • B0662012800004 ()
  • B0662012800003 ()
201280-000

  • General-purpose surgical suction system, vacuum
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