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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 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
Original Opaque
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059561 ()
  • D0019059540 ()
  • D0019060222 ()

  • Weight: 1000 Gram
905954

  • Dental appliance fabrication material, resin
Dark Pink
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019060212 ()
  • D0019059451 ()
  • D0019059350 ()

  • Weight: 1000 Gram
905935

  • Dental appliance fabrication material, resin
Light Reddish Pink
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059441 ()
  • D0019059340 ()
  • D0019060202 ()

  • Weight: 1000 Gram
905934

  • Dental appliance fabrication material, resin
Light
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019060192 ()
  • D0019059431 ()
  • D0019059330 ()

  • Weight: 1000 Gram
905933

  • Dental appliance fabrication material, resin
Original
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059421 ()
  • D0019059320 ()
  • D0019060182 ()

  • Weight: 1000 Gram
905932

  • Dental appliance fabrication material, resin
Quala Mask Surgical Molded Pink
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCPKA
In Commercial Distribution

  • D023GCPKA5 ()
  • D023GCPKA3 ()
  • D023GCPKA1 ()
GCPKA

  • Surgical/medical respirator, non-antimicrobial, single-use
Quala Mask Earloop Latex Free Pink
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCIPKA
In Commercial Distribution

  • D023GCIPKA5 ()
  • D023GCIPKA3 ()
  • D023GCIPKA1 ()
GCIPKA

  • Surgical/medical respirator, non-antimicrobial, single-use
Quala Mask Earloop Latex Free Blue
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCIBLA
In Commercial Distribution

  • D023GCIBLA5 ()
  • D023GCIBLA3 ()
  • D023GCIBLA1 ()
GCIBLA

  • Surgical/medical respirator, non-antimicrobial, single-use
Quala Mask Earloop Latex Free Lavender
NATIONAL DISTRIBUTION & CONTRACTING, INC.
GCILVA
In Commercial Distribution

  • D023GCILVA50 ()
  • D023GCILVA3 ()
  • D023GCILVA1 ()
GCILVA

  • Surgical/medical respirator, non-antimicrobial, single-use
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