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
Thermocouple, Pediatric
CADWELL INDUSTRIES, INC.
302548-200-0280
In Commercial Distribution

  • 00840067103272 ()

  • Length: 200 Centimeter


  • Home-use sleep apnoea recording system
  • Polysomnograph
RIPmate™ Belt, Pediatric
CADWELL INDUSTRIES, INC.
302521-200-0200
In Commercial Distribution

  • 00840067103180 ()


  • Home-use sleep apnoea recording system
  • Polysomnograph
RIPmate™ Abdominal Processor Alice 5
CADWELL INDUSTRIES, INC.
302519-200-9000
In Commercial Distribution

  • 00840067103173 ()

  • Length: 15 Millimeter


  • Polysomnograph
  • Home-use sleep apnoea recording system
RIPmate™ Abdominal Processor
CADWELL INDUSTRIES, INC.
302519-200-0000
In Commercial Distribution

  • 00840067103166 ()

  • Length: 15 Millimeter


  • Home-use sleep apnoea recording system
  • Polysomnograph
RIPmate™ Thoracic Processor Alice 5
CADWELL INDUSTRIES, INC.
302518-200-9000
In Commercial Distribution

  • 00840067103159 ()

  • Length: 15 Millimeter


  • Home-use sleep apnoea recording system
  • Polysomnograph
RIPmate™ Thoracic Processor
CADWELL INDUSTRIES, INC.
302518-200-0000
In Commercial Distribution

  • 00840067103142 ()

  • Length: 15 Millimeter


  • Polysomnograph
  • Home-use sleep apnoea recording system
UARS Disposable Sensors
CADWELL INDUSTRIES, INC.
302553-200-0000
In Commercial Distribution

  • 00840067103944 ()


  • Polysomnograph
  • Home-use sleep apnoea recording system
Disposable Thermistor Sensor, Large/Adult
CADWELL INDUSTRIES, INC.
302551-200-0400
In Commercial Distribution

  • 00840067103937 ()


  • Polysomnograph
  • Home-use sleep apnoea recording system
Disposable Thermistor Sensor, Small/Infant
CADWELL INDUSTRIES, INC.
302551-200-0100
In Commercial Distribution

  • 00840067103920 ()


  • Home-use sleep apnoea recording system
  • Polysomnograph
Velstretch Band 1in Buckle
CADWELL INDUSTRIES, INC.
302525-200-0000
In Commercial Distribution

  • 00840067103692 ()


  • Polysomnograph
  • Home-use sleep apnoea recording system
Velstretch Band Large 1.5in Velcro
CADWELL INDUSTRIES, INC.
302523-200-0500
In Commercial Distribution

  • 00840067103685 ()


  • Polysomnograph
  • Home-use sleep apnoea recording system
Velstretch Band Medium 1.5in Velcro
CADWELL INDUSTRIES, INC.
302523-200-0400
In Commercial Distribution

  • 00840067103678 ()


  • Polysomnograph
  • Home-use sleep apnoea recording system
Velstretch Band Small
CADWELL INDUSTRIES, INC.
302523-200-0300
In Commercial Distribution

  • 00840067103661 ()


  • Home-use sleep apnoea recording system
  • Polysomnograph
Velstretch Band Infant 1in Loop
CADWELL INDUSTRIES, INC.
302523-200-0100
In Commercial Distribution

  • 00840067103654 ()


  • Home-use sleep apnoea recording system
  • Polysomnograph
RIPmate Disposable Belt Roll
CADWELL INDUSTRIES, INC.
302513-200-0000
In Commercial Distribution

  • 00840067103647 ()


  • Home-use sleep apnoea recording system
  • Polysomnograph
Disposable Thermistor Sensor, Medium/Pediatric
CADWELL INDUSTRIES, INC.
302551-200-0200
In Commercial Distribution

  • 00840067103579 ()


  • Home-use sleep apnoea recording system
  • Polysomnograph
Pressure Transducer Alice 5
CADWELL INDUSTRIES, INC.
302570-200-9000
In Commercial Distribution

  • 00840067103470 ()

  • Length: 15 Millimeter


  • Polysomnograph
  • Home-use sleep apnoea recording system
Triple Thermocouple Airflow Sensor
CADWELL INDUSTRIES, INC.
302562-200-0000
In Commercial Distribution

  • 00840067103463 ()

  • Length: 200 Centimeter


  • Polysomnograph
  • Home-use sleep apnoea recording system
Pressure Transducer
CADWELL INDUSTRIES, INC.
302570-200-0000
In Commercial Distribution

  • 00840067103449 ()

  • Length: 15 Millimeter


  • Home-use sleep apnoea recording system
  • Polysomnograph
Piezo Snore Sensor
CADWELL INDUSTRIES, INC.
302561-200-1078
In Commercial Distribution

  • 00840067103432 ()

  • Length: 198 Centimeter


  • Polysomnograph
  • Home-use sleep apnoea recording system
Piezo Film Sensor
CADWELL INDUSTRIES, INC.
302569-200-0080
In Commercial Distribution

  • 00840067103425 ()

  • Length: 200 Centimeter


  • Polysomnograph
  • Home-use sleep apnoea recording system
Piezo Double Loop Sensor
CADWELL INDUSTRIES, INC.
302568-200-0080
In Commercial Distribution

  • 00840067103418 ()

  • Length: 200 Centimeter


  • Polysomnograph
  • Home-use sleep apnoea recording system
Piezo Sensor Buckle SNAP Labs
CADWELL INDUSTRIES, INC.
302567-200-9080
In Commercial Distribution

  • 00840067103401 ()

  • Length: 200 Centimeter


  • Polysomnograph
  • Home-use sleep apnoea recording system
Piezo Velcro Tab Sensor
CADWELL INDUSTRIES, INC.
302566-200-0080
In Commercial Distribution

  • 00840067103395 ()

  • Length: 200 Centimeter


  • Polysomnograph
  • Home-use sleep apnoea recording system
Piezo Buckle Sensor Alice 5
CADWELL INDUSTRIES, INC.
302565-200-9080
In Commercial Distribution

  • 00840067103388 ()

  • Length: 200 Centimeter


  • Polysomnograph
  • Home-use sleep apnoea recording system
Snore Microphone
CADWELL INDUSTRIES, INC.
302563-200-1024
In Commercial Distribution

  • 00840067103371 ()

  • Length: 60 Centimeter


  • Polysomnograph
  • Home-use sleep apnoea recording system
Snore Microphone
CADWELL INDUSTRIES, INC.
302556-200-9080
In Commercial Distribution

  • 00840067103364 ()

  • Length: 200 Centimeter


  • Home-use sleep apnoea recording system
  • Polysomnograph
Snore Microphone
CADWELL INDUSTRIES, INC.
302556-200-0080
In Commercial Distribution

  • 00840067103357 ()

  • Length: 200 Centimeter


  • Home-use sleep apnoea recording system
  • Polysomnograph
Piezo Snore Sensor
CADWELL INDUSTRIES, INC.
302555-200-1024
In Commercial Distribution

  • 00840067103340 ()

  • Length: 60 Centimeter


  • Home-use sleep apnoea recording system
  • Polysomnograph
Piezo Snore Sensor
CADWELL INDUSTRIES, INC.
302555-200-0080
In Commercial Distribution

  • 00840067103333 ()

  • Length: 200 Centimeter


  • Polysomnograph
  • Home-use sleep apnoea recording system
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