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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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The Pulmogine Vibrating Mesh Nebulizer is a small, handheld, internally powered general-purpose nebulizer which utilizes vibrating mesh technology to generate aerosol. The Pulmogine Vibrating Mesh Nebulizer is designed for a single patient, multiple uses, and mainly composed of a Main Unit and a Medication Reservoir. The Main Unit contains the control circuitry and the firmware to control the vibrating mesh module in the Medication Reservoir and is powered by 2 AA alkaline batteries or an AC adaptor. The Medication Reservoir contains the nebulizing module (mesh) where the liquid medication will be turned into aerosols. The prescribed medication is added into the reservoir with ten (10) ml of medication capacity, nebulized, and inhaled through the aerosol port. The Pulmogine Vibrating Mesh Nebulizer generates aerosol from liquid medication during turning on through pressing ON/OFF button and turning off when pressing ON/OFF button again, auto-turn off when no liquid detected, or 10-minute session completed. There are different LED lights to monitor the status and operating condition of the nebulizer: green indicates power on and normally working, yellow flash indicates low power caution, and constant yellow indicates shut-off due to too low power.
HCMED INNOVATIONS CO., LTD.
HCM-86C
In Commercial Distribution

  • 04719873130030 ()


  • Benchtop nebulizer, non-heated
An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
HOME SKINOVATIONS LTD
Lumea Comfort SC1981
In Commercial Distribution

  • 00075020040312 ()
  • 20075020040316 ()
  • 10075020040319 ()
075020040312

  • Cosmetic red-light phototherapy system, home-use
An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
HOME SKINOVATIONS LTD
IPL3500
In Commercial Distribution

  • 00074590550863 ()
  • 10074590550860 ()
  • 20074590550867 ()
0074590550863

  • Cosmetic red-light phototherapy system, home-use
CLIPPER, SURGICAL, LED, CHARGER & BASE
MEDLINE INDUSTRIES, INC.
CLIP5515
In Commercial Distribution

  • 10193489016963 ()
CLIP5515

  • Surgical hair clippers
CHARGING BASE FOR CLIP5515, CLIP5513E
MEDLINE INDUSTRIES, INC.
CLIP5514A
In Commercial Distribution

  • 10193489016956 ()
CLIP5514A

  • Surgical hair clippers
The flat panel detector, when used with a radiographic imaging system, is intended to generate radiographic images of human anatomy wherever a conventional screen-film, digital radiography (DR) or computed radiography (CR) detector is used for general purposes.
KA Imaging Inc
1
In Commercial Distribution

  • 00628011941015 ()
101

  • Indirect flat panel x-ray detector
The Insight Infrared Video Goggles Pro+ are intended for viewing and recording eye movements in support of identifying vestibular disorders in patients. The device is intended for use only by a trained healthcare professional in an appropriate healthcare setting. This device provides no diagnoses nor does it provide diagnostic recommendations. The target population is 12+ years of age.
Vestibular First, LLC
Insight Infrared Video Goggles Pro+
In Commercial Distribution

  • 10860002280742 ()
  • 00860002280745 ()
INSIGHT-PRO-PLUS

  • Eye/eyelid movement monitoring spectacles/goggles
The Insight Infrared Video Goggles Pro are intended for viewing and recording eye movements in support of identifying vestibular disorders in patients. The device is intended for use only by a trained healthcare professional in an appropriate healthcare setting. This device provides no diagnoses nor does it provide diagnostic recommendations. The target population is 12+ years of age.
Vestibular First, LLC
Insight Infrared Video Goggles Pro
In Commercial Distribution

  • 10860002280735 ()
  • 00860002280738 ()
INSIGHT-VIDEO-GOGGLES-PRO

  • Eye/eyelid movement monitoring spectacles/goggles
The disposable cushion for the Insight series of Video Goggles are designed for settings where infection control is top priority. The cushions are easy to replace with simple hook and loop connection, comfortable for patients, and have excellent light-blocking properties. Cushions are one-time use and are not reusable. This box contains 40 cushions.
Vestibular First, LLC
Insight Disposable Cushions - 40-Count
In Commercial Distribution

  • 00860002280714 ()
PART-DISPOSABLE-CUSHION-40CT

  • Eye/eyelid movement monitoring spectacles/goggles
The Insight Infrared Video Goggles are designed to be used by clinicians to visualize and record patient eye movements. The goggles will be placed on the patient’s head with the cameras in front of the patient’s eyes. The infrared cameras transmit video of the eye movements to a compatible computer screen for display. The computer uses an off-the-shelf video software Open Broadcaster Software (OBS) to allow viewing and recording of the cameras.
Vestibular First, LLC
Insight Infrared Video Goggles
In Commercial Distribution

  • 10860002280704 ()
  • 00860002280707 ()


  • Vision/eye movement analysis system
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