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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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The BiWaze Clear System assists patients in loosening and mobilizing secretions as well as treating and preventing atelectasis by providing lung expansion and high frequency oscillation therapies. The BiWaze Clear System may be used with a patient interface like face mask, mouthpiece, a trach adapter to a patient’s endotracheal or tracheostomy tube. It is for use on adult or paediatric patients in acute, post-acute, and home care environments. The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 2 years in the acute care setting. The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 5 years in the home care setting
Abmrc LLC
BK181
In Commercial Distribution

  • B965BK367 ()
  • B965BK181 ()
  • B965BK368 ()
BK181

  • In-exsufflation/lung-oscillation airway secretion-clearing system
BUS 250 V P F CHLA
UTAK LABORATORIES, INC.
BUS 250 V P F CHLA
In Commercial Distribution

  • B800BUS250VPFCHLA5 ()
  • B800BUS250VPFCHLA0 ()
  • B800BUS250VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 250 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN 10 NG/ML
UTAK LABORATORIES, INC.
BUS 10 V P F CHLA
In Commercial Distribution

  • B800BUS10VPFCHLA5 ()
  • B800BUS10VPFCHLA0 ()
  • B800BUS10VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 10 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN 1000 NG/ML
UTAK LABORATORIES, INC.
BUS 1000 V P F CHLA
In Commercial Distribution

  • B800BUS1000VPFCHLA5 ()
  • B800BUS1000VPFCHLA0 ()
  • B800BUS1000VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 1000 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
90006 is a kit containing two off-the-shelf components. - 1: (61922) 10M-10F Straight Connector with 7.6 mm Port - 2: (61921) Luer Elbow, fits 7.6 mm Port The two pieces fit together to provide a sampling port which fits on a 10mm-diameter breathing circuit.
Beyond Air, Inc.
90006
In Commercial Distribution

  • B882900061 ()
  • B882900060 ()
  • B882900062 ()


  • Nitric oxide delivery system, secondary
The integrated Backup NO delivery system is a completely independent backup NO generating system that is separate from the main delivery system; it has its own NO generator and gas flow delivery system. Backup NO flow can be delivered to one of two different locations by using the System Selector switch located on the front panel of the LungFit PH system. When the Selector Switch is turned to “Bagging System” position, the backup NO module turns on and delivers 1 L/min of 220 ppm of NO through a separate internal NO2 filter to the Bagging System connector on the front panel of the LungFit PH system. The Bagging System connector has two tubing fittings: one for connecting to an air/oxygen source through oxygen tubing or equivalent to provide an external flow of air/oxygen and the other to connect to a manual resuscitator for manually ventilating a patient. The 1 L/min NO flow from the backup NO module is added to this air/oxygen flow which dilutes the NO concentration down to therapeutic levels. Final NO concentration will depend on the amount of external flow added; for example, a flow of 10 L/min will provide 20 ppm of NO to the patient.
Beyond Air, Inc.
90005
In Commercial Distribution

  • B882900051 ()
  • B882900050 ()
  • B882900052 ()


  • Nitric oxide delivery system, secondary
Black Nitrile Gloves with Diamond Grip, X-Large
Raven Industrial Supply, Inc.
Kuervo 3D
In Commercial Distribution

  • G344XL209975 ()
  • G344209975X0 ()
  • G344XL229975 ()
209975XL

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Black Nitrile Gloves with Diamond Grip, Medium
Raven Industrial Supply, Inc.
Kuervo 3D
In Commercial Distribution

  • G344209975M0 ()
  • G344MD209975 ()
  • G344MD22997508 ()
209975MD

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Disposable breath alcohol test
Alcopro Inc.
CP08
In Commercial Distribution

  • G354CCP082002 ()
  • G354CCP082001 ()
  • G354CCP082003 ()
  • G354CCP082000 ()
CCP08200

  • Alcohol breath analyser
Disposable breath alcohol test
Alcopro Inc.
CP04
In Commercial Distribution

  • G354CCP042002 ()
  • G354CCP042001 ()
  • G354CCP042003 ()
  • G354CCP042000 ()
CCP04200

  • Alcohol breath analyser
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