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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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Adult Nasal Pressure Monitoring Cannula with 2' (.6 m) tube with filter.
SALTER LABS
5011-2
In Commercial Distribution

  • 10607411007962 ()
  • 00607411007965 ()

  • Adult
5011-2

  • Respiratory apnoea monitoring system
PneumoTherm Oral/Nasal Thermal Air Flow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal.
SALTER LABS
5800-0-1
In Commercial Distribution

  • 00607411006906 ()
5800-0-1

  • Respiratory apnoea monitoring system
PneumoTherm™ Adaptor Cable (5810). The 5810 PneumoTherm™ Adaptor Cable is used as an interface between the 5800T and the PSG System using Din Connectors.
SALTER LABS
5810-0
In Commercial Distribution

  • 00607411006890 ()
5810

  • Respiratory apnoea monitoring system
PneumoTherm Sensor (Adult) Kit- (10) #5800T, (1)#5810, (1) #5751, (1)#5761, (1)#1001
SALTER LABS
5800-0
In Commercial Distribution

  • 00607411006883 ()

  • Adult
5800-0

  • Respiratory apnoea monitoring system
PneumoTherm (Adult) Oral/Nasal Thermal Air Flow Sensor
SALTER LABS
5800T-0-10
In Commercial Distribution

  • 10607411006873 ()
  • 00607411006876 ()

  • Adult
5800T-0-10

  • Respiratory apnoea monitoring system
ThermiSense® Oral/Nasal Thermal Air Flow Sensor for use with the Sandman® SD20 PSG System. Reusable.
SALTER LABS
5700S20-0
In Commercial Distribution

  • 00607411005725 ()

  • Adult
5700S20-0

  • Respiratory apnoea monitoring system
ThermiSense® Nasal Air Flow Pressure and Gas Sampling Cannula (Adult) with Thermistor Holder with 7’ (2.1 m) tubes with male/female connector for gas sampling and pressure monitoring.
SALTER LABS
5742-7-7
In Commercial Distribution

  • 10607411005593 ()
  • 00607411005596 ()

  • Adult
5742-7-7

  • Respiratory apnoea monitoring system
Pediatric (Small) Oral/Nasal Pressure Monitoring Cannula with 7' (2.1 m) tube with male Luer-lock connection.
SALTER LABS
5036-7
In Commercial Distribution

  • 10607411005401 ()
  • 00607411005404 ()
  • 20607411005408 ()

  • Pediatric
5036-7

  • Respiratory apnoea monitoring system
Pediatric Oral/Nasal Pressure Monitoring Cannula with 7’ (2.1 m) tube with filter.
SALTER LABS
5037-7
In Commercial Distribution

  • 20607411005385 ()
  • 10607411005388 ()
  • 00607411005381 ()

  • Pediatric
5037-7

  • Respiratory apnoea monitoring system
Pediatric Oral/Nasal Pressure Monitoring Cannula with 7’ (2.1 m) tube with male luer connection.
SALTER LABS
5038-7
In Commercial Distribution

  • 10607411005371 ()
  • 00607411005374 ()
  • 20607411005378 ()

  • Pediatric
5038-7

  • Respiratory apnoea monitoring system
Adult Oral/Nasal Pressure Monitoring Cannula with 1' (0.3 m) tube with male Luer-lock connection.
SALTER LABS
5006-1
In Commercial Distribution

  • 10607411000888 ()
  • 00607411000881 ()

  • Adult
5006-1

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

  • 00607411000492 ()

  • Adult
5700PEK-2-0

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

  • 00607411000485 ()

  • Adult
5700PEK-0

  • Respiratory apnoea monitoring system
ThermiSense® Oral/Nasal Air Flow Pressure and Gas Sampling Cannula (Adult) with Thermistor Holder 7’ (2.1 m) tubes with male/female connector for gas sampling and pressure monitoring.
SALTER LABS
5744-7-7
In Commercial Distribution

  • 10607411000451 ()
  • 00607411000454 ()
  • 20607411000458 ()

  • Adult
5744-7-7

  • Respiratory apnoea monitoring system
ThermiSense® Oral/Nasal Air Flow Pressure Cannula (Adult) with Thermistor Holder, 2' (0.61 m) tube with male/female adaptor without filter
SALTER LABS
5761-2
In Commercial Distribution

  • 10607411000437 ()
  • 00607411000430 ()
  • 20607411000434 ()

  • Adult
5761-2

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

  • 00607411000416 ()

  • Adult
5700EK-2-0

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

  • 00607411000300 ()

  • Pediatric
5700PE-0

  • Respiratory apnoea monitoring system
ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor two conductor grey lead wires 6' long Malleable plastic coated "T" shaped with 2 nasal and 1 oral elements for thermal airflow. 2.5 mm mono sub-mini plug to connection to the Alice® 3 PSG System.
SALTER LABS
5730P-0
In Commercial Distribution

  • 00607411000256 ()

  • Pediatric
5730P-0

  • Respiratory apnoea monitoring system
ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor without Interface Box (5700B). Reusable.
SALTER LABS
5700PT-0
In Commercial Distribution

  • 00607411000249 ()

  • Pediatric
5700PT

  • Respiratory apnoea monitoring system
ThermiSense® Pediatric Oral/Nasal Thermal Air Flow Sensor two conductor grey lead wires 6' long Malleable plastic coated "T" shaped with 2 nasal and 1 oral elements for thermal airflow. Two female touch proof 1.5 mm Din Connectors for connection to the Alice® 5 PSG System.
SALTER LABS
5700PA5-0
In Commercial Distribution

  • 00607411000232 ()

  • Pediatric
5700PA5-0

  • Respiratory apnoea monitoring system
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
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