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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, 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 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
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.
201190-000
In Commercial Distribution

  • B0662011900006 ()
  • B0662011900000 ()
  • B0662011900005 ()
  • B0662011900004 ()
  • B0662011900003 ()
201190-000

  • 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.
201180-000
In Commercial Distribution

  • B0662011800006 ()
  • B0662011800000 ()
  • B0662011800005 ()
  • B0662011800004 ()
  • B0662011800003 ()
201180-000

  • 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.
201164-000
In Commercial Distribution

  • B0662011640006 ()
  • B0662011640000 ()
  • B0662011640005 ()
  • B0662011640004 ()
  • B0662011640003 ()
201164-000

  • 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.
201135-000
In Commercial Distribution

  • B0662011350006 ()
  • B0662011350000 ()
  • B0662011350005 ()
  • B0662011350004 ()
  • B0662011350003 ()
201135-000

  • General-purpose surgical suction system, vacuum
A collection of sterile, flexible, double-bore tubing, and associated items (typically includes clamps, filters, spikes, and connectors), used as twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution to a surgical field through one bore and provide aspiration (suction) through the other during a surgical procedure (e.g., tissue/bone morcellation, ENT, neuro and general surgery). The tubing is made of synthetic material and is of a fixed diameter that may be specific to the requirements of the clinical application for which it is intended. This is a single-use device.
NOVOSCI CORP.
201095-000
In Commercial Distribution

  • B0662010950006 ()
  • B0662010950000 ()
  • B0662010950005 ()
  • B0662010950004 ()
  • B0662010950003 ()
201095-000

  • Surgical irrigation/aspiration tubing set
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