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-Pedia 1-1/2" Band
Ambu A/S
819102-000
In Commercial Distribution

  • 05707480041091 ()
819102-000

  • Polysomnograph
RIPmate Belt-Adult 1-1/2" Band
Ambu A/S
819103-000
In Commercial Distribution

  • 05707480041084 ()
819103-000

  • Polysomnograph
IntelliVue Cableless Respiration Pod, a battery-powered respiration device for frequent Cableless Monitoring of patients. The IntelliVue CL Respiration Pod provides the respiration rate and optional the pulse rate via short range radio to the receiving system.
Philips Medizin Systeme Böblingen GmbH
IntelliVue CL Respiration Pod
In Commercial Distribution

  • 00884838020689 ()
865218

  • Respiration monitor
DISPOSABLE ULTRAFLOW RESPIRATION MONITORS: LARGE, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL), 1 ORAL & 2 NASAL RECORDING POINTS
ROCHESTER ELECTRO-MEDICAL, INC.
603775
Not in Commercial Distribution

  • 10816843021440 ()
  • 10816843021457 ()


  • Patient monitoring system module, electrocardiographic/respiratory
REUSABLE ULTRAFLOW RESPIRATION MONITOR: SMALL, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL), 1 ORAL & 2 NASAL RECORDING POINTS
ROCHESTER ELECTRO-MEDICAL, INC.
603706
Not in Commercial Distribution

  • 10816843021426 ()


  • Patient monitoring system module, electrocardiographic/respiratory
REUSABLE ULTRAFLOW RESPIRATION MONITOR: LARGE, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL), 1 ORAL & 2 NASAL RECORDING POINTS
ROCHESTER ELECTRO-MEDICAL, INC.
603700
Not in Commercial Distribution

  • 10816843021402 ()


  • Patient monitoring system module, electrocardiographic/respiratory
NO CASING MULTIFLOW RESPIRATION MONITOR: SINGLE THERMOCOUPLE, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL)
ROCHESTER ELECTRO-MEDICAL, INC.
602548
Not in Commercial Distribution

  • 10816843021389 ()


  • Patient monitoring system module, electrocardiographic/respiratory
TAPES-TO-NOSE RESPIRATION MONITOR: EXTRA SMALL, 1 CHANNEL
ROCHESTER ELECTRO-MEDICAL, INC.
602532
Not in Commercial Distribution

  • 10816843021365 ()


  • Patient monitoring system module, electrocardiographic/respiratory
NO CASING MULTIFLOW RESPIRATION MONITOR: DUAL THERMOCOUPLE, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL)
ROCHESTER ELECTRO-MEDICAL, INC.
602353
Not in Commercial Distribution

  • 10816843021341 ()


  • Patient monitoring system module, electrocardiographic/respiratory
MICROSNORE SNORING MICROPHONE: 1.25" MICROPHONE DIAMETER, 6 FT. (1.8 M) WIRE
ROCHESTER ELECTRO-MEDICAL, INC.
300530
Not in Commercial Distribution

  • 10816843021327 ()


  • Patient monitoring system module, electrocardiographic/respiratory
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