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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 device intended to hold, position, and organize medical/surgical interventional tubing (e.g., arterial/venous lines, gas lines, drainage catheters) or cables to an equipment, drape or gown; it is not intended to affix the tubing to the patient directly. It is typically designed as a clip or a block with clips. This is a single-use device.
NOVOSCI CORP.
311033-000
In Commercial Distribution

  • B0663110330005 ()
  • B0663110330000 ()
  • B0663110330003 ()
  • B0663110330007 ()
  • B0663110330006 ()
311033-000

  • Medical/surgical interventional tube/cable securement clip, 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.
301400-000
In Commercial Distribution

  • B0663014000007 ()
  • B0663014000000 ()
  • B0663014000006 ()
  • B0663014000005 ()
  • B0663014000003 ()
301400-000

  • Cardiopulmonary bypass system filter, arterial blood line
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.
301178-000
In Commercial Distribution

  • B0663011780006 ()
  • B0663011780000 ()
  • B0663011780005 ()
  • B0663011780004 ()
  • B0663011780003 ()
301178-000

  • 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.
301177-000
In Commercial Distribution

  • B0663011770006 ()
  • B0663011770000 ()
  • B0663011770005 ()
  • B0663011770004 ()
  • B0663011770003 ()
301177-000

  • 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.
301121-000
In Commercial Distribution

  • B0663011210006 ()
  • B0663011210000 ()
  • B0663011210005 ()
  • B0663011210004 ()
  • B0663011210003 ()
301121-000

  • Cardioplegia solution administration adaptor
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.
NOVOSCI CORP.
301103-000
In Commercial Distribution

  • B0663011030007 ()
  • B0663011030000 ()
  • B0663011030006 ()
  • B0663011030005 ()
  • B0663011030003 ()
301103-000

  • Basic intravenous administration set, noninvasive
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.
NOVOSCI CORP.
301094-000
Not in Commercial Distribution

  • B0663010940007 ()
  • B0663010940000 ()
  • B0663010940006 ()
  • B0663010940005 ()
  • B0663010940003 ()
301094-000

  • Stopcock
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.
301028-000
In Commercial Distribution

  • B0663010280006 ()
  • B0663010280000 ()
  • B0663010280005 ()
  • B0663010280004 ()
  • B0663010280003 ()
301028-000

  • 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.
301027-000
In Commercial Distribution

  • B0663010270006 ()
  • B0663010270000 ()
  • B0663010270005 ()
  • B0663010270004 ()
  • B0663010270003 ()
301027-000

  • 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.
301026-000
In Commercial Distribution

  • B0663010260006 ()
  • B0663010260000 ()
  • B0663010260005 ()
  • B0663010260004 ()
  • B0663010260003 ()
301026-000

  • 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.
301022-000
In Commercial Distribution

  • B0663010220006 ()
  • B0663010220000 ()
  • B0663010220005 ()
  • B0663010220004 ()
  • B0663010220003 ()
301022-000

  • 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.
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
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