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
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
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
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
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
0581
In Commercial Distribution

  • B14005810 ()
0581

  • Air/gas pressure transducer
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 Esophageal Balloon Catheters; 2 Micro Cannulae; 2 Oral + Nasal Cannulae.
Braebon Medical Corporation
0580PES
In Commercial Distribution

  • B1400580PES0 ()
0580PES

  • Air/gas pressure transducer
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 Pressure Sensor; Pneumo Flow Sensor; Dual 1 mm Keyhole to Keyhole Cable; Adapter Cable; Dual 1 mm Keyhole male to female cable.
Braebon Medical Corporation
0580-NOX
In Commercial Distribution

  • B1400580NOX0 ()
0580-NOX

  • Air/gas pressure transducer
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 Pressure Sensor; Ultima Pressure Sensor Interface: Pure, Filter, Snoring; Interface Strap; 3 Micro Cannulae; 2 Oral + Nasal Cannulae.
Braebon Medical Corporation
0580L
In Commercial Distribution

  • B1400580L0 ()
0580L

  • Air/gas pressure transducer
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 1 Ultima Dual Pressure Sensor; 2 Micro Nasal Cannulae; 2 Oral + Nasal Cannulae.
Braebon Medical Corporation
0580D
In Commercial Distribution

  • B1400580D0 ()
0580D

  • Air/gas pressure transducer
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 1 Ultima Pressure Sensor; 1 Interface Cable for Alice 6.
Braebon Medical Corporation
0580A
In Commercial Distribution

  • B1400580AXA0 ()
0580A

  • Air/gas pressure transducer
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 1 Ultima Dual Pressure Sensor; 2 Interface cables; 1 Pressure Sensor Interface; 2 Micro Cannulae; 2 Oral + Nasal Cannulae.
Braebon Medical Corporation
0580A
Not in Commercial Distribution

  • B1400580A0 ()
0580A

  • Air/gas pressure transducer
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 1 Ultima Pressure Sensor; 1 Connector Cable; 3 Micro Cannulae; 2 Oral + Nasal Cannulae.
Braebon Medical Corporation
0580
In Commercial Distribution

  • B14005800 ()
0580

  • Air/gas pressure transducer
Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode head box or a DC amplifier.
Braebon Medical Corporation
0579
In Commercial Distribution

  • B14005790 ()

  • Length: 83 Inch
0579

  • Electrical-only medical device connection cable, reusable
Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode head box or a DC amplifier.
Braebon Medical Corporation
0578
In Commercial Distribution

  • B14005780 ()

  • Length: 83 Inch
0578

  • Electrical-only medical device connection cable, reusable
Cable for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
0574
In Commercial Distribution

  • B14005740 ()
0574

  • Electrical-only medical device connection cable, reusable
Cable for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
0573A
In Commercial Distribution

  • B1400573A0 ()
0573A

  • Electrical-only medical device connection cable, reusable
Cable for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
0573
In Commercial Distribution

  • B14005730 ()
0573

  • Electrical-only medical device connection cable, reusable
Pediatric belt for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
0572PED
In Commercial Distribution

  • B1400572PED0 ()

  • Length: 24 Inch
0572PED

  • Pneumograph
Belt for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
0572L
In Commercial Distribution

  • B1400572L0 ()

  • Length: 72 Inch
0572L

  • Pneumograph
Pediatric belt for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
0572APED
In Commercial Distribution

  • B1400572APED0 ()
  • B1400572APED1 ()
  • B1400572APED21 ()

  • Length: 24 Inch
0572APED

  • Pneumograph
Belt for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
0572AL
In Commercial Distribution

  • B1400572AL0 ()

  • Length: 72 Inch
0572AL

  • Pneumograph
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