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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REUSABLE ULTRAFLOW RESPIRATION MONITOR: LARGE, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL), 1 ORAL & 2 NASAL RECORDING POINTS
Advantage Medical Electronics, LLC
SM-603700
In Commercial Distribution

  • 00849593015615 ()


  • Patient monitoring system module, electrocardiographic/respiratory
NO CASING MULTIFLOW RESPIRATION MONITOR: SINGLE THERMOCOUPLE, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL)
Advantage Medical Electronics, LLC
SM-602548
In Commercial Distribution

  • 00849593015608 ()


  • Patient monitoring system module, electrocardiographic/respiratory
DUAL NO CASING RESP. MONITOR
Advantage Medical Electronics, LLC
SM-602353
In Commercial Distribution

  • 00849593015585 ()


  • Patient monitoring system module, electrocardiographic/respiratory
Nasal Cannula PG/PSG
SALTER LABS
70710316
In Commercial Distribution

  • 30889483610569 ()
  • 10889483610565 ()


  • Respiratory apnoea monitoring system
PneumoTherm™ Adaptor Cable "REUSABLE" 6" Wire for use with the PneumoTherm™ Thermocouple.
SALTER LABS
5811-0
In Commercial Distribution

  • 00607411889745 ()
5811

  • Respiratory apnoea monitoring system
SnoreTAC® adapter replaces the Snore Microphone when used with BiNAPS®. Use during CPAP Titration.
SALTER LABS
5531-0
In Commercial Distribution

  • 10607411801133 ()
  • 00607411801136 ()

  • Adult
5531-0

  • Respiratory apnoea monitoring system
Replaces Snore Microphone when used with BiNAPS® Snore Sensing Adapter for BiNAPS® use during CPAP Titration. SO-1990, ABM
SALTER LABS
5530-0
In Commercial Distribution

  • 00607411801105 ()
  • 10607411801102 ()
SO-1990

  • Respiratory apnoea monitoring system
Adult Nasal Pressure Monitoring Cannula with 2' (0.6 m) tube with male Luer-Lock connection.
SALTER LABS
5012-2
In Commercial Distribution

  • 10607411801065 ()
  • 00607411801068 ()

  • Adult
5012-2

  • Respiratory apnoea monitoring system
Adult Oral/Nasal Pressure Monitoring Cannula with 2' (0.6 m) tube with male Luer-lock connection.
SALTER LABS
5006-2
In Commercial Distribution

  • 10607411500623 ()
  • 00607411500626 ()

  • Adult
5006-2

  • Respiratory apnoea monitoring system
Adult Oral/Nasal Pressure Monitoring Cannula with 2’ (0.6 m) tube with filter.
SALTER LABS
5005-2
In Commercial Distribution

  • 10607411500616 ()
  • 00607411500619 ()

  • Adult
5005-2

  • Respiratory apnoea monitoring system
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