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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ThermiSense® (Pediatric) Oral/Nasal Thermal Air Flow Sensor Alice®3 with Airflow Pressure Cannulas, Nasal and Oral/Nasal.
SALTER LABS
5700PA3-0-1
In Commercial Distribution

  • 00607411000201 ()

  • Pediatric
57009A3-0-1

  • Respiratory apnoea monitoring system
ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal.
SALTER LABS
5700P-0
In Commercial Distribution

  • 00607411000195 ()

  • Pediatric
57009-0

  • Respiratory apnoea monitoring system
ThermiSense® Nasal Air Flow Pressure and Gas Sampling Cannula (Pediatric) with Thermistor Holder with 2’ (0.6 m) tubes with male/female connector for gas sampling and pressure monitoring.
SALTER LABS
5754-2-2
In Commercial Distribution

  • 10607411000185 ()
  • 00607411000188 ()

  • Adult
5754-2-2

  • Respiratory apnoea monitoring system
ThermiSense® Nasal Air Flow Pressure and Gas Sampling Cannula (Pediatric) with Thermistor Holder with 7’ (2.1 m) tubes with male/female connector for gas sampling and pressure monitoring.
SALTER LABS
5754-7-7
In Commercial Distribution

  • 20607411000175 ()
  • 10607411000178 ()
  • 00607411000171 ()

  • Adult
5754-7-7

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

  • 00607411000164 ()

  • Adult
5700EK-0

  • Respiratory apnoea monitoring system
Bubble Humidifier with 3 PSI safety valve.
SALTER LABS
NP7100-0
In Commercial Distribution

  • 10607411920094 ()
  • 00607411920097 ()

  • Small Pediatric
NP7100

  • Non-heated respiratory humidifier
BiNAPS® ADAPTER FOR USE WITH ALICE 5* PSG SYSTEM ALICE 5 is a trademark of Respironics Inc.
SALTER LABS
5520-0
In Commercial Distribution

  • 00607411915963 ()

  • Adult
5520-0

  • Respiratory apnoea monitoring system
ThermiSense® (Pediatric) Oral/Nasal Thermal Air Flow Sensor for use with a PSG System. Reusable.
SALTER LABS
5700PCK-2-0-1
In Commercial Distribution

  • 00607411893476 ()

  • Pediatric
5700PCK-2-0-1

  • Respiratory apnoea monitoring system
ThermiSense® Oral/Nasal Thermal Air Flow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal.
SALTER LABS
5700CK-2-0
In Commercial Distribution

  • 00607411891847 ()

  • Adult
5700CK-2-0

  • Respiratory apnoea monitoring system
PneumoTherm™ Adaptor Cable "REUSABLE" 6" Wire for use with the PneumoTherm™ Thermocouple.
SALTER LABS
5811-0
In Commercial Distribution

  • 00607411889745 ()
5811

  • Respiratory apnoea monitoring system
SnoreTAC® adapter replaces the Snore Microphone when used with BiNAPS®. Use during CPAP Titration.
SALTER LABS
5531-0
In Commercial Distribution

  • 10607411801133 ()
  • 00607411801136 ()

  • Adult
5531-0

  • Respiratory apnoea monitoring system
Replaces Snore Microphone when used with BiNAPS® Snore Sensing Adapter for BiNAPS® use during CPAP Titration. SO-1990, ABM
SALTER LABS
5530-0
In Commercial Distribution

  • 00607411801105 ()
  • 10607411801102 ()
SO-1990

  • Respiratory apnoea monitoring system
Adult Nasal Pressure Monitoring Cannula with 2' (0.6 m) tube with male Luer-Lock connection.
SALTER LABS
5012-2
In Commercial Distribution

  • 10607411801065 ()
  • 00607411801068 ()

  • Adult
5012-2

  • Respiratory apnoea monitoring system
No Description
Respironics, Inc.
1143241
In Commercial Distribution

  • 00606959057487 ()
1143241

  • Airway temperature monitoring system
Synergy E Host Software for SmartMonitor 2 Product Line
CIRCADIANCE, LLC
101483
In Commercial Distribution

  • B036101483 ()
101483

  • Infant apnoea monitor
LEAD WIRE BULK PACK
Conmed Corporation
1514848000
Not in Commercial Distribution

  • 20653405064210 ()
  • 10653405064213 ()
  • 00653405064216 ()
1514848000

  • Electrocardiographic lead set, reusable
Radiotranslucent DIN SKT 72 Inch Leadwire
Conmed Corporation
RTRG72-05
Not in Commercial Distribution

  • 10653405003106 ()
RTRG72-05

  • Electrocardiographic lead set, reusable
Radiotranslucent DIN SKT 48 Inch Leadwire
Conmed Corporation
RTRG48-05
Not in Commercial Distribution

  • 10653405003090 ()
RTRG48-05

  • Electrocardiographic lead set, reusable
Radiotranslucent DIN SKT 36 Inch Leadwire
Conmed Corporation
RTRG36-05
Not in Commercial Distribution

  • 10653405003083 ()
RTRG36-05

  • Electrocardiographic lead set, reusable
Unshielded, 72 Inch, 3 lead, grabber connector
Conmed Corporation
RDL72-03
In Commercial Distribution

  • 20653405000805 ()
  • 10653405000808 ()
  • 00653405000801 ()
RDL72-03

  • Electrocardiographic lead set, reusable
DISPOSABLE L/W:SFTY;72",5LD,GRAB,BLACK,BROWN,GREEN,WHITE,RED
Conmed Corporation
RDL72-05
In Commercial Distribution

  • 20653405000799 ()
  • 10653405000792 ()
  • 00653405000795 ()
RDL72-05

  • Electrocardiographic lead set, reusable
Oral only thermocouple intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for recording onto a data acquisition system.
Braebon Medical Corporation
B1220
In Commercial Distribution

  • B140B12210 ()
B1220

  • General-purpose patient temperature probe, 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 MediByte. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
8592A
In Commercial Distribution

  • B1408592A0 ()

  • Length: 48 Inch
8592A

  • Pneumograph
Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
8592
In Commercial Distribution

  • B14085920 ()

  • Length: 48 Inch
8592

  • Pneumograph
Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode head box or a DC amplifier.
Braebon Medical Corporation
8579
In Commercial Distribution

  • B14085790 ()

  • Length: 14 Inch
8579

  • 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 MediByte. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode head box or a DC amplifier.
Braebon Medical Corporation
8578
In Commercial Distribution

  • B14085780 ()

  • Length: 14 Inch
8578

  • Electrical-only medical device connection cable, reusable
Belt intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte.
Braebon Medical Corporation
8574
In Commercial Distribution

  • B14085740 ()

  • Length: 74 Inch
8574

  • Pneumograph
Belt intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte.
Braebon Medical Corporation
8572PED
In Commercial Distribution

  • B1408572PED0 ()

  • Length: 24 Inch
8572PED

  • Pneumograph
Belt intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte.
Braebon Medical Corporation
8572
In Commercial Distribution

  • B14085720 ()

  • Length: 48 Inch
8572

  • Pneumograph
Cannula thermistor intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for use with MediByte.
Braebon Medical Corporation
8514L
In Commercial Distribution

  • B1408514L0 ()
8514L

  • General-purpose patient temperature probe, reusable
Cannula thermistor intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for use with MediByte.
Braebon Medical Corporation
8514
In Commercial Distribution

  • B14085140 ()
8514

  • General-purpose patient temperature probe, reusable
Cable for attaching the MediByte Disposable Airflow Sensor.
Braebon Medical Corporation
8510BS
In Commercial Distribution

  • B1408510BS0 ()
8510BS

  • Electrical-only medical device connection cable, reusable
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
5581
In Commercial Distribution

  • B14055810 ()
5581

  • Air/gas pressure transducer
Disposable belt 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
5576-24
In Commercial Distribution

  • B14055710 ()
  • B1405576241 ()

  • Length: 40 Inch
5576-24

  • Pneumograph
Disposable belt 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
5575-24
In Commercial Distribution

  • B14055710 ()
  • B1405575241 ()

  • Length: 30 Inch
5575-24

  • Pneumograph
Disposable belt 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
5574-24
In Commercial Distribution

  • B14055710 ()
  • B1405574241 ()

  • Length: 17.7 Inch
5574-24

  • Pneumograph
Disposable belt 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
5573-24
In Commercial Distribution

  • B1405573241 ()
  • B14055730 ()

  • Length: 39 Inch
5573-24

  • Pneumograph
Disposable belt 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
5572-24
Not in Commercial Distribution

  • B1405572241 ()
  • B14055720 ()

  • Length: 27.5 Inch
5572-24

  • Pneumograph
Disposable belt 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
5571-24
In Commercial Distribution

  • B1405571241 ()
  • B14055710 ()

  • Length: 17.7 Inch
5571-24

  • Pneumograph
Respiratory effort sensor is intended for use during sleep disorder studies as a qualitative measure of respiratory effort for recording onto a data acquisition system. The sensor plugs directly into the electrode headbox.
Braebon Medical Corporation
5527
In Commercial Distribution

  • B14055270 ()
5527

  • Pneumograph
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