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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
MEDISYSTEMS CORPORATION
B3-3632M3705
Not in Commercial Distribution

  • M535B33632M37055 ()
  • M535B33632M37050 ()


  • Haemodialysis blood tubing set, single-use
No Description
HELENA LABORATORIES CORPORATION
5088
In Commercial Distribution

  • M52550881 ()
  • M52550880 ()


  • Faecal occult blood IVD, kit, rapid colorimetric, clinical
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
Disposable Instant Cold Pack
GF HEALTH PRODUCTS, INC.
C101
In Commercial Distribution

  • M368C1012 ()
  • M368C1011 ()


  • Hot/cold therapy pack, single-use
Disposable Instant Cold Pack
GF HEALTH PRODUCTS, INC.
C100
In Commercial Distribution

  • M368C1002 ()
  • M368C1001 ()


  • Hot/cold therapy pack, single-use
Deluxe Alternating Pressure Pump
GF HEALTH PRODUCTS, INC.
AQ2000-2
In Commercial Distribution

  • M368AQ200022 ()
  • M368AQ200021 ()


  • Alternating-pressure pump
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