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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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Ostial Perfusion Cannula
Spyder Medical
CV.CP01007
In Commercial Distribution

  • B270CVCP010070 ()
  • B270CVCP0100702 ()
  • B270CVCP010071 ()
CV.CP01007

  • Vascular irrigation cannula, coronary artery, single-use
Ostial Perfusion Cannula
Spyder Medical
CV.CP01006
In Commercial Distribution

  • B270CVCP010060 ()
  • B270CVCP010062 ()
  • B270CVCP010061 ()
CV.CP01006

  • Vascular irrigation cannula, coronary artery, single-use
Ostial Perfusion Cannula
Spyder Medical
CV.CP01005
In Commercial Distribution

  • B270CVCP010050 ()
  • B270CVCP010052 ()
  • B270CVCP010051 ()
CV.CP01005

  • Vascular irrigation cannula, coronary artery, single-use
Ostial Perfusion Cannulae
Spyder Medical
CV.CP01004
In Commercial Distribution

  • B270CVCP010040 ()
  • B270CVCP010042 ()
  • B270CVCP010041 ()
CV.CP01004

  • Vascular irrigation cannula, coronary artery, single-use
Thermometer
TOMY INTERNATIONAL, INC.
Y7916
In Commercial Distribution

  • B268Y79161 ()
  • B268Y79160 ()
  • B268Y791695 ()
Y7916

  • General-purpose patient temperature probe, reusable
American Red Cross Infrared non-Contact Forehead Thermometer
TOMY INTERNATIONAL, INC.
Y7790
In Commercial Distribution

  • B268Y77904 ()
  • B268Y77901 ()
  • B268Y77900 ()
Y7790

  • General-purpose patient temperature probe, reusable
Health and Grooming Kit
TOMY INTERNATIONAL, INC.
Y7057A5
In Commercial Distribution

  • B268Y7057A51 ()
  • B268Y7057A53 ()
  • B268Y7057A59 ()
Y7057A5

  • Infant care kit
Ear Thermometer
TOMY INTERNATIONAL, INC.
Y10896
In Commercial Distribution

  • B268Y108964 ()
  • B268Y108961 ()
  • B268Y108960 ()
Y10896

  • General-purpose patient temperature probe, reusable
The Assurance® Nasal Alar SpO2™ Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (weighing > 30kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision. The Assurance® Nasal Alar SpO2™ Sensor is for use with compatible pulse oximeters. These include: Nellcor OxiMax and Oxisensor II compatible monitors and Philips FAST compatible monitors.
XHALE ASSURANCE, INC.
301-11214
In Commercial Distribution

  • B213301112140 ()
  • B213301112141 ()
  • B213301112142 ()


  • Pulse oximeter probe, single-use
The Assurance® Nasal Alar SpO2™ Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (weighing > 30kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision. The Assurance® Nasal Alar SpO2™ Sensor is for use with compatible pulse oximeters. These include: Nellcor OxiMax and Oxisensor II compatible monitors and Philips FAST compatible monitors.
XHALE ASSURANCE, INC.
0303
In Commercial Distribution

  • B21303031 ()
  • B21303030 ()
  • B21303032 ()


  • Pulse oximeter probe, single-use
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