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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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There are two NO2 filters in the LungFit PH; the main 12 hr NO2 filter (p/n 90008) that the user can change and the internal bagging 48 hr NO2 filter p/n 90009). The purpose of the NO2 filters is to remove NO2 from the NO gas flow and to collect any particulates that may be in the gas flow path. When the main 12 hr filter is inserted, this NO2 filter communicates with the LungFit device through an RFID wireless chip that is mounted on the filter. The RFID chip on the filter tracks and updates with the filter’s remaining usage time to prevent the filter from being accidently re-used after it has been consumed. The RFID also communicates wirelessly with the Gas Monitoring CPU, as described below. The NO2 filter includes two 1µm filters and two 5µm filters, with the NO2 filter material Sofnolime (soda lime) sandwiched between the particulate filters. Soda lime is a material that is commonly used in anesthesia CO2 absorbers. The duration of use for each main filter is pre-established as 12 hours. The RFID tag tracks filter usage so that the remaining time is updated continually every minute and displayed on the device user interface (i.e., as Time Remaining). The Gas Monitoring CPU detects whether a filter is installed and displays the Change Filter alarm to alert the user to change/insert a new user when no NO2 filter is present. The device also displays the Change Filter alarm when the NO2 filter has been consumed (no more minutes remaining). The internal Bagging NO2 filter is the same basic design as the main NO2 filter that is inserted on the front of the device. The bagging NO2 filter’s useful life is 48 hours because the concentration of NO delivered through this filter is always 20 ppm at 10 L/min whereas up to 80ppm NO can be delivered through the main NO2 filter (or four times more than the backup system). The filter time remaining is tracked in the backup delivery microprocessors nonvolatile memory instead of on a RFID tag like the main NO2 Filter.
Beyond Air, Inc.
90009
In Commercial Distribution

  • B882900091 ()
  • B882900090 ()
  • B882900092 ()


  • Nitric oxide delivery system, secondary
There are two NO2 filters in the LungFit PH; the main 12 hr NO2 filter (p/n 90008) that the user can change and the internal bagging 48 hr NO2 filter p/n 90009). The purpose of the NO2 filters is to remove NO2 from the NO gas flow and to collect any particulates that may be in the gas flow path. When the main 12 hr filter is inserted, this NO2 filter communicates with the LungFit device through an RFID wireless chip that is mounted on the filter. The RFID chip on the filter tracks and updates with the filter’s remaining usage time to prevent the filter from being accidently re-used after it has been consumed. The RFID also communicates wirelessly with the Gas Monitoring CPU, as described below. The NO2 filter includes two 1µm filters and two 5µm filters, with the NO2 filter material Sofnolime (soda lime) sandwiched between the particulate filters. Soda lime is a material that is commonly used in anesthesia CO2 absorbers. The duration of use for each main filter is pre-established as 12 hours. The RFID tag tracks filter usage so that the remaining time is updated continually every minute and displayed on the device user interface (i.e., as Time Remaining). The Gas Monitoring CPU detects whether a filter is installed and displays the Change Filter alarm to alert the user to change/insert a new user when no NO2 filter is present. The device also displays the Change Filter alarm when the NO2 filter has been consumed (no more minutes remaining).
Beyond Air, Inc.
90008
In Commercial Distribution

  • B882900081 ()
  • B882900080 ()
  • B882900082 ()


  • Nitric oxide delivery system, secondary
90007 is a kit containing two off-the-shelf components: - 1: (61920) 15M-15F 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 15mm-diameter breathing circuit.
Beyond Air, Inc.
90007
In Commercial Distribution

  • B882900071 ()
  • B882900070 ()
  • B882900072 ()


  • Nitric oxide delivery system, secondary
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
MAX BITE Bite Registration Mint Chocolate Chip Super Fast - MARK3®*
CARGUS INTERNATIONAL, INC
1177
In Commercial Distribution

  • D79611772 ()
  • D79611771 ()
  • D79611773 ()
  • D796117717 ()
1177

  • Silicone dental impression material
Bite Registration Mint Chocolate Chip Fast Set 2/bx. - MARK3 EU
CARGUS INTERNATIONAL, INC
1176
In Commercial Distribution

  • D796117616 ()
  • D7961176 ()
  • D79611762 ()
  • D79611763 ()


  • Silicone dental impression material
Bite Registration Hard Bite Fast Set 2/bx. - MARK3 EU
CARGUS INTERNATIONAL, INC
1173
In Commercial Distribution

  • D796117313 ()
  • D7961173 ()
  • D79611732 ()
  • D79611733 ()


  • Silicone dental impression material
Bite Registration Super Fast Set 2/bx. - MARK3 EU
CARGUS INTERNATIONAL, INC
1172
In Commercial Distribution

  • D796117212 ()
  • D7961172 ()
  • D79611722 ()
  • D79611723 ()


  • Silicone dental impression material
Bite Registration Fast Set 2/bx. - MARK3 EU
CARGUS INTERNATIONAL, INC
1171
In Commercial Distribution

  • D796117111 ()
  • D79611710 ()
  • D79611712 ()
  • D79611713 ()


  • Silicone dental impression material
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