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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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
No Description
ICU MEDICAL, INC.
1102
In Commercial Distribution

  • 08426638170700 ()
  • 08426638179901 ()


  • General-purpose multi-parameter bedside monitor
Adult Divided Nasal Pressure Monitoring & Gas Sampling Cannula with modified nasal prongs Salter Eyes, and 7’ (2.1 m) tubes with male/female connector for gas sampling and filter for pressure monitoring
SALTER LABS
5018-7-7-25
In Commercial Distribution

  • 10607411500098 ()

  • Adult
5018-7-7-25

  • Respiratory apnoea monitoring system
BiNAPS® SLEEP DIAGNOSTIC KIT
SALTER LABS
5500-0-1
In Commercial Distribution

  • 10607411301022 ()

  • Adult
5500-0-1

  • Respiratory apnoea monitoring system
ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor for use with a PSG System. Reusable.
SALTER LABS
5700PE-0-1
In Commercial Distribution

  • 10607411000307 ()

  • Pediatric
5700PE-0-1

  • Respiratory apnoea monitoring system
Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system. Kit contains Ultima Dual Pressure Sensor; 2 Dual Pressure Sensor Safety Filter + Adapter; 2 Micro Cannulae; 2 Oral + Nasal Cannulae.
Braebon Medical Corporation
0580PES
Not in Commercial Distribution

  • B1400585PESXA0 ()
0580PES

  • Air/gas pressure transducer
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