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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 KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.
KOWA COMPANY,LTD.
DE2K
Not in Commercial Distribution

  • 04987646807728 ()


  • Ophthalmic fundus camera
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 09357123000051 ()
MXU-RV71

  • Mobile basic diagnostic x-ray system, digital
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 09357123000044 ()
MXU-RV60

  • Mobile basic diagnostic x-ray system, digital
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 09357123000037 ()
MXU-RV35

  • Mobile basic diagnostic x-ray system, digital
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 09357123000013 ()
MXU-RV19

  • Mobile basic diagnostic x-ray system, digital
The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxygen saturation and pulse rate for adults in a home-use only. This device is not intended for continuous monitoring. The device is intended to use of Over-The-Counter.
GOLDEN SMART HOME TECHNOLOGY CORP.
GSH601
In Commercial Distribution

  • 04719878124027 ()
  • 14719878124024 ()
  • 54719878124022 ()

  • Weight: 50 Gram
  • Height: 58 Millimeter
  • Width: 34 Millimeter
  • Depth: 30 Millimeter
Orange

  • Pulse oximeter
The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxygen saturation and pulse rate for adults in a home-use only. This device is not intended for continuous monitoring. The device is intended to use of Over-The-Counter.
GOLDEN SMART HOME TECHNOLOGY CORP.
GSH601
In Commercial Distribution

  • 04719878124010 ()
  • 14719878124017 ()
  • 54719878124015 ()

  • Weight: 50 Gram
  • Height: 58 Millimeter
  • Width: 34 Millimeter
  • Depth: 30 Millimeter
Gray

  • Pulse oximeter
The Aerogen®Go Vibrating Mesh Nebulizer is a small, handheld, internally powered general-purpose nebulizer which utilizes vibrating mesh technology to generate aerosol. The Aerogen®Go 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 Aerogen®Go 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

  • 04719873130191 ()


  • Benchtop nebulizer, non-heated
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
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