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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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CARDINAL HEALTH - 10195594348335

UNIVERSITY EAR PACK
Cardinal Health 200, LLC
SNE15EPFC3
In Commercial Distribution

  • 50195594348333 ()
  • 10195594348335 ()
SNE15EPFC3

  • ENT surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10198956100688

UNIVERSITY PACEMAKER PACK
Cardinal Health 200, LLC
SAN15UPM39
In Commercial Distribution

  • 50198956100686 ()
  • 10198956100688 ()
SAN15UPM39

  • Cardiothoracic surgical procedure kit, medicated, single-use

GSR-TMP Combination Sensor (NC-C-GT) - 08719481550097

NC-C-GT: The GSR sensor provides a measure of skin resistance or skin conductance when connected to a NeXus signal acquisition device, which is influenced by the autonomic activation of sweat glands in the skin. The sensor output is not intended to be used for vital monitoring purposes. The temperature sensor provides a signal that corresponds with (variations in) peripheral skin temperature when connected to a NeXus signal acquisition device. The sensor shall be placed on intact skin to provide a signal that is influenced by cutaneous blood flow. The sensor is not intended to determine directly or indirectly a measure of core body temperature and to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.
Mind Media Europe B.V.
1.0
In Commercial Distribution

  • 08719481550097 ()


  • General-purpose patient temperature probe, reusable
  • Skin electrical conductance meter

Temperature Sensor (NB-TMP) - 08719481550080

NB-TMP: The temperature sensor provides a signal that corresponds with (variations in) peripheral skin temperature when connected to a NeXus signal acquisition device. The sensor shall be placed on intact skin to provide a signal that is influenced by cutaneous blood flow. The sensor is not intended to determine directly or indirectly a measure of core body temperature and to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.
Mind Media Europe B.V.
1.0
In Commercial Distribution

  • 08719481550080 ()


  • General-purpose patient temperature probe, reusable

Galvanic Skin Response Sensor (NB-GSR) - 08719481550073

NB-GSR: The GSR sensor provides a measure of skin resistance or skin conductance when connected to a NeXus signal acquisition device, which is influenced by the autonomic activation of sweat glands in the skin. The sensor output is not intended to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.
Mind Media Europe B.V.
1.0
In Commercial Distribution

  • 08719481550073 ()


  • Skin electrical conductance meter

Blood Volume Pulse Sensor (NC-BVP-H) - 08719481550066

NC-BVP-H (head module): The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition device, that corresponds with variations in peripheral blood flow resulting from cardiovascular activity and responses, with the purpose of providing information on the cardiovascular variations such as heart rate variations and measured pulse amplitude. The sensor output is not intended to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.
Mind Media Europe B.V.
1.0
In Commercial Distribution

  • 08719481550066 ()


  • Photometer, reflectance

Blood Volume Pulse Sensor (NC-BVP-F) - 08719481550059

NC-BVP-F (finger module): The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition device, that corresponds with variations in peripheral blood flow resulting from cardiovascular activity and responses, with the purpose of providing information on the cardiovascular variations such as heart rate variations and measured pulse amplitude. The sensor output is not intended to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.
Mind Media Europe B.V.
1.0
In Commercial Distribution

  • 08719481550059 ()


  • Plethysmography phototransducer

Blood Volume Pulse Sensor (NB-BVP-H) - 08719481550042

NB-BVP-H (head module): The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition device, that corresponds with variations in peripheral blood flow resulting from cardiovascular activity and responses, with the purpose of providing information on the cardiovascular variations such as heart rate variations and measured pulse amplitude. The sensor output is not intended to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.
Mind Media Europe B.V.
1.0
In Commercial Distribution

  • 08719481550042 ()


  • Photometer, reflectance

Blood Volume Pulse Sensor (NB-BVP-F) - 08719481550035

NB-BVP-F (finger module): The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition device, that corresponds with variations in peripheral blood flow resulting from cardiovascular activity and responses, with the purpose of providing information on the cardiovascular variations such as heart rate variations and measured pulse amplitude. The sensor output is not intended to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.
Mind Media Europe B.V.
1.0
In Commercial Distribution

  • 08719481550035 ()


  • Plethysmography phototransducer

NeXus-Q32 - 08719481550004

The NeXus-Q32 is intended for acquisition of (electro)-physiological signals (e.g. EEG, surface EMG or ECG) from humans, regardless of any specific medical indication, by medical/research professionals.
Mind Media Europe B.V.
2.0
In Commercial Distribution

  • 08719481550004 ()


  • Multiple physiological signal amplifier
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