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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Ultrasonic Scalers
Guilin Woodpecker Medical Instrument Co., Ltd.
V2 LED
In Commercial Distribution

  • 06944843600130 ()


  • Ultrasonic dental scaling/debridement system
Forehead and Ear Infrared Thermometer - Upgraded Firmware
KONQUEST GROUP INC
KDT-2106 V2
In Commercial Distribution

  • 00869378000421 ()


  • Infrared patient thermometer, ear
The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM CORPORATION
EG-600WR v2
In Commercial Distribution

  • 04547410337402 ()
  • 14547410337409 ()


  • Flexible video gastroduodenoscope
This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
FUJIFILM CORPORATION
EC-600WL v2
In Commercial Distribution

  • 04547410337396 ()
  • 14547410337393 ()


  • Flexible video colonoscope, reusable
This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
FUJIFILM CORPORATION
EC-530LS V2
In Commercial Distribution

  • 04547410341294 ()


  • Flexible video colonoscope, reusable
This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
FUJIFILM CORPORATION
EC-530HL V2
In Commercial Distribution

  • 04547410341287 ()


  • Flexible video colonoscope, reusable
The NObreath® is a portable, non-invasive device for the measurement of Fractional Exhaled Nitric Oxide (FeNO) in human breath. The production of nitric oxide is often found to be increased in inflammatory conditions such as asthma. Measurement of FeNO by NObreath® is a method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy, as an indication of the therapeutic effect in patients with elevated FeNO levels. The fractional NO concentration in expired breath (FeNO), can be measured by NObreath® according to guidelines for NO measurement established by the American Thoracic Society. NObreath® is intended for children, 7- 17 years, and adults 18 years and older. NObreath® 12 second test mode is for age 7 and up NObreath® 10 second test mode is for ages 7-10 only who cannot successfully complete a 12 second test. FeNO measurements provide the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. The NObreath® cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation. NObreath® should not be used in critical care, emergency care or in anesthesiology.
BEDFONT SCIENTIFIC LIMITED
NOBreath V2
In Commercial Distribution

  • 05060246860177 ()
NOBREATH-V2

  • Nitric oxide breath analyser
No Description
GO MEDICAL INDUSTRIES PTY. LTD.
V2 GSS
In Commercial Distribution

  • 9350902000044 ()
  • 09350902000013 ()
  • 9350902000037 ()
  • 9350902000020 ()
V2GSSR

  • Basic intravenous administration set, noninvasive
Vasculitis Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4 V2
In Commercial Distribution

  • 00847865002394 ()

  • 1 Each
6651870D

  • Multiple vasculitis-associated antibody IVD, kit, multiplex
EBV IgG Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4 V2
In Commercial Distribution

  • 00847865002226 ()

  • 1 Each
6651270C

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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