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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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Cadwell - 00840067103159

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

Cadwell - 00840067103142

RIPmate™ Thoracic Processor
CADWELL INDUSTRIES, INC.
302518-200-0000
In Commercial Distribution

  • 00840067103142 ()

  • Length: 15 Millimeter


  • Polysomnograph
  • Home-use sleep apnoea recording system

BCI - 08426638170700

No Description
ICU MEDICAL, INC.
1102
In Commercial Distribution

  • 08426638170700 ()
  • 08426638179901 ()


  • General-purpose multi-parameter bedside monitor

N/A - 10607411500098

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 - 10607411301022

BiNAPS® SLEEP DIAGNOSTIC KIT
SALTER LABS
5500-0-1
In Commercial Distribution

  • 10607411301022 ()

  • Adult
5500-0-1

  • Respiratory apnoea monitoring system

ThermiSense - 10607411000307

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

BRAEBON Ultima Esophageal Pressure Transducer - B1400585PESXA0

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

Ultima Dual Pressure Sensor. - B14005850

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.
Braebon Medical Corporation
0585
In Commercial Distribution

  • B14005850 ()
0585

  • Air/gas pressure transducer

BRAEBON Interface Strap - B14005840

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.
Braebon Medical Corporation
0584
In Commercial Distribution

  • B14005840 ()

  • Length: 12 Inch
0584

  • Electrode/transducer strap, reusable
  • Air/gas pressure transducer

BRAEBON Ultima Pressure Sensor - B1400581L0

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.
Braebon Medical Corporation
0581L
In Commercial Distribution

  • B1400581L0 ()
0581L

  • Air/gas pressure transducer
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