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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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Rescuer disposable adult manual resuscitator with pressure release valve, 2900 mL reservoir, #5 cushion mask and 2 m crush proof oxygen tubing
B.L.S. Systems Limited
4050
In Commercial Distribution

  • B00240506 ()
  • B00240500 ()
  • B00240501 ()

  • Adult
4050

  • Pulmonary resuscitator, manual, single-use
Rescuer disposable infant manual resuscitator with 800 mL reservoir, #1 cushion mask and 2 m crush proof oxygen tubing.
B.L.S. Systems Limited
4025
In Commercial Distribution

  • B00240256 ()
  • B00240250 ()
  • B00240251 ()

  • Infant
4025

  • Pulmonary resuscitator, manual, single-use
Rescuer Child Size manual resuscitator with 2900 mL reservoir, #3 cushion mask and 2 m crush proof oxygen tubing (each)
B.L.S. Systems Limited
4010
In Commercial Distribution

  • B00240100 ()
  • B00240106 ()
  • B00240101 ()

  • Child
4010

  • Pulmonary resuscitator, manual, single-use
Disposable PEEP valve for use on the Rescuer manual resuscitator.
B.L.S. Systems Limited
4000-PEEP
In Commercial Distribution

  • B0024000PEEP3 ()
  • B0024000PEEP0 ()
  • B0024000PEEP2 ()
4000-PEEP

  • PEEP valve, single-use
HEPA Filter component for Rescuer BVM Manual Resuscitator (Emergency Manual Ventilator)
B.L.S. Systems Limited
4000F
In Commercial Distribution

  • B0024000F0 ()
  • B0024000F2 ()
  • B0024000F3 ()
4000F

  • Microbial medical gas filter, single-use
Rescuer adult disposable manual resuscitator with 2900 mL reservoir bag, #5 cushion mask and 2 m crush proof oxygen tubing (Single Unit)
B.L.S. Systems Limited
4000
In Commercial Distribution

  • B00240000 ()
  • B00240006 ()
  • B00240001 ()

  • Adult
4000

  • Pulmonary resuscitator, manual, single-use
Locking Cap
Kalitec Direct LLC
11-LCL-0000
In Commercial Distribution

  • B07311LCL00000 ()
  • B07311LCL00002 ()
  • B07311LCL00001 ()


  • Bone-screw internal spinal fixation system, non-sterile
Impsoft data management & analysis software
IMPEDIMED LIMITED
2.2.0
In Commercial Distribution

  • B277292U400CD2 ()
  • B277292U400CD1 ()
  • B277292U400CD0 ()
292-U400CD

  • Bioelectrical body composition analyser
DF50 Body Composition Analysis Software
IMPEDIMED LIMITED
4.1.2
Not in Commercial Distribution

  • B277292DF50CD1 ()
  • B277292DF50CD0 ()
  • B277292DF50CD2 ()
292-DF50CD

  • Bioelectrical body composition analyser
SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via dry electrode, and displaying the results on a monitor.
IMPEDIMED LIMITED
2727000
In Commercial Distribution

  • B27727270000 ()
  • B27727270001 ()
  • B27727270002 ()
2727000

  • Bioelectrical body composition analyser
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