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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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No Description
LED TECHNOLOGIES INC
BA568810
In Commercial Distribution

  • B347BA5688101 ()
  • B347BA5688100 ()
  • B347BA5688102 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA568210
In Commercial Distribution

  • B347BA5682101 ()
  • B347BA5682100 ()
  • B347BA5682102 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA568110
In Commercial Distribution

  • B347BA5681101 ()
  • B347BA5681100 ()
  • B347BA5681102 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA567410
In Commercial Distribution

  • B347BA5674102 ()
  • B347BA5674101 ()
  • B347BA5674100 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA567210
Not in Commercial Distribution

  • B347BA5672101 ()
  • B347BA5672100 ()
  • B347BA5672102 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
BA567010
Not in Commercial Distribution

  • B347BA5670102 ()
  • B347BA5670101 ()
  • B347BA5670100 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
5756
In Commercial Distribution

  • B34757561 ()
  • B34757560 ()
  • B34757562 ()


  • Blue/red/infrared phototherapy lamp
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
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 (REF 0201-A01) is for use with Philips FAST SpO2 compatible monitors.
XHALE ASSURANCE, INC.
0201-A01
In Commercial Distribution

  • B2130201A012 ()
  • B2130201A011 ()
  • B2130201A010 ()


  • Pulse oximeter probe, single-use
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