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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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Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.
Shenzhen Leqing Medical Instrument Co., LTD
uNeck-9515A
In Commercial Distribution

  • 06974700021013 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.
Shenzhen Leqing Medical Instrument Co., LTD
uNeck-9512A
In Commercial Distribution

  • 06974700021006 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
FLEXICARE MEDICAL LIMITED
038-31-748U
In Commercial Distribution

  • 05055788711964 ()


  • Heated respiratory humidifier
  • Ventilator breathing circuit, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-31-768U
In Commercial Distribution

  • 05055788711957 ()


  • Ventilator breathing circuit, single-use
  • Heated respiratory humidifier
No Description
FLEXICARE MEDICAL LIMITED
038-35-963U
In Commercial Distribution

  • 05055788709664 ()


  • Heated respiratory humidifier
  • Ventilator breathing circuit, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-35-964U
In Commercial Distribution

  • 05055788709657 ()


  • Ventilator breathing circuit, single-use
  • Heated respiratory humidifier
The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controlling patient temperature in adult patients. Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings. Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery.
AUGUSTINE TEMPERATURE MANAGEMENT LLC
U530
In Commercial Distribution

  • 00855913001848 ()
U530

  • Electric pad whole-body heating system
  • Electrosurgical return electrode, reusable
The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controlling patient temperature in adult patients. Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings. Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery.
AUGUSTINE TEMPERATURE MANAGEMENT LLC
U502
In Commercial Distribution

  • 00855913001824 ()
U502

  • Electric pad whole-body heating system
  • Electrosurgical return electrode, reusable
The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controlling patient temperature in adult patients. Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings. Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery.
AUGUSTINE TEMPERATURE MANAGEMENT LLC
U501
In Commercial Distribution

  • 00855913001817 ()
U501

  • Electric pad whole-body heating system
  • Electrosurgical return electrode, reusable
The Swift® applicator handpiece connects to the Swift® microwave generator via the Swift® interconnect cable.
EMBLATION LIMITED
SWF-HP01
In Commercial Distribution

  • 05060652910022 ()
SWF-HP01

  • Microwave hyperthermia system applicator, extracorporeal
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