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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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Paxis 100 Auto Left Hand
Pausch, L.L.C.
LH
In Commercial Distribution

  • B884S10000110L0 ()
S10000110L

  • X-ray system tube support, floor standing
Paxis 100 Right Hand
Pausch, L.L.C.
RH
In Commercial Distribution

  • B884S10000100R0 ()
S10000100R

  • X-ray system tube support, floor standing
Paxis 100 Left Hand
Pausch, L.L.C.
LH
In Commercial Distribution

  • B884S10000100L0 ()
S10000100L

  • X-ray system tube support, floor standing
No Description
Pausch, L.L.C.
Right Hand
In Commercial Distribution

  • B884S06211100R0 ()
S 0621 1100RH

  • Diagnostic X-ray system positioning frame
No Description
Pausch, L.L.C.
Left Hand
In Commercial Distribution

  • B884S06211100L0 ()
S 0621 1100LH

  • Diagnostic X-ray system positioning frame
No Description
Pausch, L.L.C.
R
In Commercial Distribution

  • B884S04201000R0 ()
S 0420 1000R

  • X-ray system tube support, ceiling mounted
No Description
Pausch, L.L.C.
L
In Commercial Distribution

  • B884S04201000L0 ()
S 0420 1000L

  • X-ray system tube support, ceiling mounted
Nitric oxide (NO) is generated by the LungFit PH from room air just prior to delivery into an attached breathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide, nitrogen dioxide (NO2) and oxygen (O2) in the breathing circuit just prior to inhalation by the patient, via a sampling line.
Beyond Air, Inc.
80013
In Commercial Distribution

  • B882800130 ()


  • Nitric oxide delivery unit, system-based
Nitric oxide (NO) is generated by the LungFit PH from room air just prior to delivery into an attached breathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide, nitrogen dioxide (NO2) and oxygen (O2) in the breathing circuit just prior to inhalation by the patient, via a sampling line.
Beyond Air, Inc.
80012
In Commercial Distribution

  • B882800120 ()


  • Nitric oxide delivery unit, system-based
No Description
RIMSA P. LONGONI SRL
Z400460-4
In Commercial Distribution

  • B880Z40046040 ()


  • Medical equipment handle cover, reusable
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