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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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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
No Description
Aktina Corp.
12-210
In Commercial Distribution

  • B3651120008102 ()
  • B365122100 ()
  • B3651120008011 ()


  • Pulmonary function testing kit
Replacement Part
ESI CORPORATION
011B1263
In Commercial Distribution

  • B360011B12632 ()
  • B360011B12630 ()
  • B360011B12631 ()

  • Length: 14 Inch
011B1263

  • Basic intravenous administration set, noninvasive
Wired TENS+EMS+HEAT Replacement Gel Pads
BEAR DOWN CONSULTING
PETNEMPD5
In Commercial Distribution

  • B311PETNEMPD51 ()
  • B311PETNEMPD5 ()
  • B311PETNEMPD52 ()


  • Transcutaneous electrical stimulation electrode, single-use
Wired TENS+EMS+HEAT Replacement Gel Pads 2 sets
BEAR DOWN CONSULTING
PETNEMPD2
In Commercial Distribution

  • B311PETNEMPD21 ()
  • B311PETNEMPD2 ()
  • B311PETNEMPD22 ()


  • Transcutaneous electrical stimulation electrode, single-use
No Description
BEAR DOWN CONSULTING
PETNEMHT
In Commercial Distribution

  • B311PETNEMHT1 ()
  • B311PETNEMHT0 ()
  • B311PETNEMHT2 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
BEAR DOWN CONSULTING
PEPULSE-RT
In Commercial Distribution

  • B311PEPULSERT0 ()
  • B311PEPULSERT1 ()
  • B311PEPULSERT2 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Reusable electrode gel pads.
BEAR DOWN CONSULTING
PEHTNPDS5
In Commercial Distribution

  • B311PEHTNPDS51 ()
  • B311PEHTNPDS50 ()
  • B311PEHTNPDS52 ()


  • Transcutaneous electrical stimulation electrode, single-use
Reusable electrode gel pads.
BEAR DOWN CONSULTING
PEHTNPDS2
In Commercial Distribution

  • B311PEHTNPDS21 ()
  • B311PEHTNPDS20 ()
  • B311PEHTNPDS22 ()


  • Transcutaneous electrical stimulation electrode, single-use
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