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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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10mm Gas Sample Adaptor - B882900060

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

LungFit PH Bagging Kit - B882900050

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

Sample Line with Nafion Tube Kit - B882900310

The Gas Sampling Line (p/n 90031) delivers a gas sample of the ventilator gas flow to the monitoring system in the LungFit PH. The gas sampling line has a male Luer lock connector at each end that is attached at one end to the inspiratory limb of the ventilator breathing circuit via the sample T adaptor (with a female Luer lock connector), near the patient connection and to the LungFit PH System female Leur Lock connector gas sampling port at the other end. The gas sample line is composed of a 12 inch length of Nafion tubing for removing moisture from the sample gas, a gas sample tube with Leur fittings and a hydrophobic filter to prevent any remaining water in the sample gas from entering the LungFit PH.
Beyond Air, Inc.
90031
In Commercial Distribution

  • B882900310 ()
  • B882900311 ()
  • B882900312 ()


  • Nitric oxide delivery system, secondary

22mm Gas Sample Adaptor Kit - B882900170

90017 is a kit containing two off-the-shelf components: - 1: (61928) 22M-22F 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 22mm-diameter breathing circuit.
Beyond Air, Inc.
90017
In Commercial Distribution

  • B882900171 ()
  • B882900170 ()
  • B882900172 ()


  • Nitric oxide delivery system, secondary

Luer Elbow 7.6mm Port Kit - B882900160

The Luer elbow is a component to the gas sampling port which fits on a breathing circuit.
Beyond Air, Inc.
90016
In Commercial Distribution

  • B882900161 ()
  • B882900160 ()
  • B882900162 ()


  • Nitric oxide delivery system, secondary

Capture - D745701031CAP00300

Monophase Crown Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0030
In Commercial Distribution

  • D745701031CAP00171 ()
  • D745701031CAP00300 ()
  • D745701028CAP00121 ()
70-1031-CAP0030

  • Silicone dental impression material

Capture - D745701031CAP00290

Monophase Bridge Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0029
In Commercial Distribution

  • D745701031CAP00181 ()
  • D745701031CAP00290 ()
  • D745701028CAP00091 ()
70-1031-CAP0029

  • Silicone dental impression material

Capture - D745701031CAP00280

Medium Crown Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0028
In Commercial Distribution

  • D745701031CAP00131 ()
  • D745701031CAP00280 ()
  • D745701028CAP00111 ()
70-1031-CAP0028

  • Silicone dental impression material

Capture - D745701031CAP00270

Medium Bridge Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0027
In Commercial Distribution

  • D745701031CAP00141 ()
  • D745701031CAP00270 ()
  • D745701028CAP00101 ()
70-1031-CAP0027

  • Silicone dental impression material

Capture - D745701031CAP00260

Light Crown Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0026
In Commercial Distribution

  • D745701031CAP00091 ()
  • D745701031CAP00260 ()
  • D745701028CAP00081 ()
70-1031-CAP0026

  • Silicone dental impression material
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