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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).
Beyond Air, Inc.
90008
In Commercial Distribution
- B882900081 ()
- B882900080 ()
- B882900082 ()
- Nitric oxide delivery unit, system-based
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 unit, system-based
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 unit, system-based
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 unit, system-based
The ResQCPR system contains two ResQPODs and one ResQPump
ADVANCED CIRCULATORY SYSTEMS INC
12-0825-000
In Commercial Distribution
- M5921208220000 ()
- M5921208250001 ()
- M5921208230001 ()
- Cardiac resuscitator, manual
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 6F & 7F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-580I
In Commercial Distribution
- M729700580I1 ()
- M729700580I0 ()
- M729700580I3 ()
- Catheter Gauge: 7 French
- Catheter Gauge: 6 French
- Femoral artery closure plug/patch, collagen
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 5F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-500DX
In Commercial Distribution
- M729700500DX1 ()
- M729700500DX0 ()
- M729700500DX3 ()
- Catheter Gauge: 5 French
- Femoral artery closure plug/patch, collagen
OCS Liver Perfusion Initiation Set
TRANSMEDICS, INC.
3400
In Commercial Distribution
- B00944895 ()
- B00944823 ()
- Length: 18 Inch
- Width: 12 Inch
- Height: 4 Inch
3400
- Donor-organ preservation/transport perfusion initiation/termination set
OCS Liver Perfusion Set
TRANSMEDICS, INC.
3200
In Commercial Distribution
- B00944707 ()
- B00944705 ()
- Length: 27 Inch
- Width: 27 Inch
- Height: 21 Inch
3200
- Liver donor-organ preservation/transport perfusion set
OCS Lung Solution
TRANSMEDICS, INC.
2300
In Commercial Distribution
- B00944671 ()
- B00944670 ()
- Height: 2.5 Inch
- Width: 5.5 Inch
- Length: 14 Inch
2300
- Donor-organ/tissue/cell preservation solution