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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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No Description
HELENA LABORATORIES CORPORATION
5078
In Commercial Distribution

  • M52550781 ()
  • M52550780 ()


  • Faecal occult blood IVD, kit, rapid colorimetric, clinical
No Description
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
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
511NS
In Commercial Distribution

  • M665511NS1 ()
  • M665511NS0 ()

  • Outer Diameter: 0.5 Inch
  • Wall: 0.09375 in.
  • Length: 50 Feet
  • Lumen/Inner Diameter: 0.3125 Inch


  • Suction/irrigation tubing, single-use
ENDOSCOPIC SEAL URO 1 SIZE FITS ALL
OBP CORPORATION
C010014
In Commercial Distribution

  • M648C0100141 ()
  • M648C0100140 ()
C010014

  • Endoscope working-channel seal
C010012 SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ URO (Customer REF 27550ZAG/10)
OBP CORPORATION
C010012
In Commercial Distribution

  • M648C0100121 ()
  • M648C0100120 ()


  • Endoscope working-channel seal
Vent Tube Donaldson 1.10mm Silicone Pair
JEDMED INSTRUMENT COMPANY
S381590 2
In Commercial Distribution

  • M63338159023 ()
  • M633S38159022 ()

  • Lumen/Inner Diameter: 1.10 Millimeter
S381590 2

  • Tympanostomy tube
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