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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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Colon Hydrotherapy Disposable Single-Use Kit, consisting of a small size Bulb Style Speculum with Obturator, a water inflow tube, a collapsible waste hose and a 2.5 g sachet of lubricant.
TRANSCENDENCIAS COMERCIALES SL
Small Hydrokit
In Commercial Distribution

  • B482Z101 ()
  • B482Z100 ()
  • B482Z102 ()
Z-10

  • Colonic lavage kit, non-surgical
Colon Hydrotherapy Disposable Single-Use Kit, consisting of a large size Bulb Style Speculum with Obturator, a water inflow tube, a collapsible waste hose and a 2.5 g sachet of lubricant.
TRANSCENDENCIAS COMERCIALES SL
Large Hydrokit
In Commercial Distribution

  • B482Z091 ()
  • B482Z090 ()
  • B482Z092 ()
Z-09

  • Colonic lavage kit, non-surgical
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
Easy Glide 60cc Luer Lock Syringe
GLOBAL DIABETIC DISTRIBUTORS INC
676660
In Commercial Distribution

  • B2086766600 ()
  • B2086766601 ()
  • B2086766603 ()


  • General-purpose syringe, single-use
Easy Glide 60cc Cath Tip Syringe
GLOBAL DIABETIC DISTRIBUTORS INC
676060
In Commercial Distribution

  • B2086760603 ()
  • B2086760601 ()
  • B2086760600 ()


  • General-purpose syringe, single-use
Easy Glide 30cc Luer Lock Syringe
GLOBAL DIABETIC DISTRIBUTORS INC
673330
In Commercial Distribution

  • B2086733303 ()
  • B2086733301 ()
  • B2086733300 ()


  • General-purpose syringe, single-use
Easy Glide 1cc Luer Lock Syringe
GLOBAL DIABETIC DISTRIBUTORS INC
671350
In Commercial Distribution

  • B2086713503 ()
  • B2086713501 ()
  • B2086713500 ()


  • General-purpose syringe, single-use
No Description
CLEAR GUIDE MEDICAL, INC.
CGTT
In Commercial Distribution

  • B201CGTT1 ()
  • B201CGTT0 ()
  • B201CGTT2 ()


  • Imaging lesion localization marker, external, single-use
  • Surgical optical-tracking spatial marker, single-use
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