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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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
No Description
Respironics, Inc.
1143241
In Commercial Distribution

  • 00606959057487 ()
1143241

  • Airway temperature monitoring system
Synergy E Host Software for SmartMonitor 2 Product Line
CIRCADIANCE, LLC
101483
In Commercial Distribution

  • B036101483 ()
101483

  • Infant apnoea monitor
LEAD WIRE BULK PACK
Conmed Corporation
1514848000
Not in Commercial Distribution

  • 20653405064210 ()
  • 10653405064213 ()
  • 00653405064216 ()
1514848000

  • Electrocardiographic lead set, reusable
Radiotranslucent DIN SKT 72 Inch Leadwire
Conmed Corporation
RTRG72-05
Not in Commercial Distribution

  • 10653405003106 ()
RTRG72-05

  • Electrocardiographic lead set, reusable
Radiotranslucent DIN SKT 48 Inch Leadwire
Conmed Corporation
RTRG48-05
Not in Commercial Distribution

  • 10653405003090 ()
RTRG48-05

  • Electrocardiographic lead set, reusable
Radiotranslucent DIN SKT 36 Inch Leadwire
Conmed Corporation
RTRG36-05
Not in Commercial Distribution

  • 10653405003083 ()
RTRG36-05

  • Electrocardiographic lead set, reusable
Unshielded, 72 Inch, 3 lead, grabber connector
Conmed Corporation
RDL72-03
In Commercial Distribution

  • 20653405000805 ()
  • 10653405000808 ()
  • 00653405000801 ()
RDL72-03

  • Electrocardiographic lead set, reusable
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