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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Adult Respiratory Sensor SpO2, RR;OxiMax (TM) Technology
Covidien LP
10068119
In Commercial Distribution

  • 20884521103389 ()
  • 10884521103382 ()

  • Patient Weight, >30, KG;


  • Transcutaneous blood gas monitor sensor
DISPOSABLE ULTRAFLOW RESPIRATION MONITORS: LARGE, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL), 1 ORAL & 2 NASAL RECORDING POINTS
ROCHESTER ELECTRO-MEDICAL, INC.
603775
Not in Commercial Distribution

  • 10816843021440 ()
  • 10816843021457 ()


  • Patient monitoring system module, electrocardiographic/respiratory
REUSABLE ULTRAFLOW RESPIRATION MONITOR: SMALL, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL), 1 ORAL & 2 NASAL RECORDING POINTS
ROCHESTER ELECTRO-MEDICAL, INC.
603706
Not in Commercial Distribution

  • 10816843021426 ()


  • Patient monitoring system module, electrocardiographic/respiratory
REUSABLE ULTRAFLOW RESPIRATION MONITOR: LARGE, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL), 1 ORAL & 2 NASAL RECORDING POINTS
ROCHESTER ELECTRO-MEDICAL, INC.
603700
Not in Commercial Distribution

  • 10816843021402 ()


  • Patient monitoring system module, electrocardiographic/respiratory
NO CASING MULTIFLOW RESPIRATION MONITOR: SINGLE THERMOCOUPLE, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL)
ROCHESTER ELECTRO-MEDICAL, INC.
602548
Not in Commercial Distribution

  • 10816843021389 ()


  • Patient monitoring system module, electrocardiographic/respiratory
TAPES-TO-NOSE RESPIRATION MONITOR: EXTRA SMALL, 1 CHANNEL
ROCHESTER ELECTRO-MEDICAL, INC.
602532
Not in Commercial Distribution

  • 10816843021365 ()


  • Patient monitoring system module, electrocardiographic/respiratory
NO CASING MULTIFLOW RESPIRATION MONITOR: DUAL THERMOCOUPLE, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL)
ROCHESTER ELECTRO-MEDICAL, INC.
602353
Not in Commercial Distribution

  • 10816843021341 ()


  • Patient monitoring system module, electrocardiographic/respiratory
MICROSNORE SNORING MICROPHONE: 1.25" MICROPHONE DIAMETER, 6 FT. (1.8 M) WIRE
ROCHESTER ELECTRO-MEDICAL, INC.
300530
Not in Commercial Distribution

  • 10816843021327 ()


  • Patient monitoring system module, electrocardiographic/respiratory
RAS-45 Inf/Neo RRa Infant/Neonatal Acoustic Respiration Sensor
MASIMO CORPORATION
4425
In Commercial Distribution

  • 00843997013116 ()
  • 10843997013113 ()


  • Electronic acoustic stethoscope
Radius VSM RAS-45 Acoustic Respiration Sensor, Adult, 10/Box
MASIMO CORPORATION
4828
In Commercial Distribution

  • 00843997006187 ()
  • 10843997006184 ()


  • Electronic acoustic stethoscope
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