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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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HELENA LABORATORIES CORPORATION
500091
In Commercial Distribution

  • M5255000910 ()
  • M52550771 ()


  • Faecal occult blood IVD, kit, rapid colorimetric, clinical
An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.
MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI
AL-1400.V005
In Commercial Distribution

  • M485AL1400V0052 ()
  • M485AL1400V0051 ()


  • Ventilator breathing circuit, single-use
An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.
MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI
AL-1100.V002
In Commercial Distribution

  • M485AL1100V0022 ()
  • M485AL1100V0021 ()


  • Ventilator breathing circuit, single-use
A device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.
MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI
AL-08021.V001
In Commercial Distribution

  • M485AL08021V0012 ()
  • M485AL08021V0011 ()


  • Heat/moisture exchanger/microbial medical gas filter
LED Rover Disoposable, Non-Sterile Series
SUNOPTIC TECHNOLOGIES LLC
Rover Lightsource series
In Commercial Distribution

  • M678SLS10 ()
  • M678SLS0 ()


  • Open surgical site internal light
Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
516NS
In Commercial Distribution

  • M665516NS0 ()
  • M665516NS1 ()

  • Lumen/Inner Diameter: 0.5 Inch
  • Outer Diameter: 0.75 Inch
  • Wall: 0.125 in.
  • Length: 50 Feet


  • Suction/irrigation tubing, single-use
Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
515NS
In Commercial Distribution

  • M665515NS1 ()
  • M665515NS0 ()

  • Lumen/Inner Diameter: 0.5 Inch
  • Outer Diameter: 0.6875 Inch
  • Wall: 0.09375in.
  • Length: 50 Feet


  • Suction/irrigation tubing, single-use
Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
514NS
In Commercial Distribution

  • M665514NS1 ()
  • M665514NS0 ()

  • Lumen/Inner Diameter: 0.375 Inch
  • Outer Diameter: 0.625 Inch
  • Wall: 0.0625 in.
  • Length: 50 Feet


  • Suction/irrigation tubing, single-use
Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
513NS
In Commercial Distribution

  • M665513NS1 ()
  • M665513NS0 ()

  • Lumen/Inner Diameter: 0.375 Inch
  • Outer Diameter: 0.4375 Inch
  • Wall: 0.09375 in.
  • Length: 50 Feet


  • Suction/irrigation tubing, single-use
Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
512NS
In Commercial Distribution

  • M665512NS0 ()
  • M665512NS1 ()

  • Lumen/Inner Diameter: 0.375 Inch
  • Outer Diameter: 0.5 Inch
  • Wall: 0.0625 in.
  • Length: 50 Feet


  • Suction/irrigation tubing, single-use
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