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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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Versana Essential R2 VS
GE Medical Systems (China) Co.,Ltd.
Essential R2 VS
In Commercial Distribution

  • 00195278503404 ()


  • General-purpose ultrasound imaging system
Vivid iq V204 to V206 SW only upgrade kit
GE Medical Systems (China) Co.,Ltd.
iq v204 to v206 UPG SW only
In Commercial Distribution

  • 00195278488527 ()


  • Cardiovascular ultrasound imaging system
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
The Light Jacket® Attachable Light for Electrosurgical Pencil is offered as a sterile, one-time use disposable medical device for providing enhanced illumination of the surgical site when attached to an electrosurgical pencil.
PATHY MEDICAL, LLC
PM-LJ100
In Commercial Distribution

  • 00860000230704 ()
  • 00860000230711 ()


  • Operating room light
VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data. The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.
VIVALNK, INC.
VV350
In Commercial Distribution

  • 00860008259233 ()


  • Electrocardiography telemetric monitoring system
The CarePath system facilitates evaluations measuring urine output. It consists of the CarePath device, accompanying documents, and training. The system: • Measures and calculates flow rate and volume from urination data • Automatically transmits urination data to a secure location • Creates and provides uroflow reports to healthcare providers The intended operator of the CarePath device is the patient. The CarePath system has no user-serviceable components. This system is not to be serviced or maintained by the user. The intended environments are hospitals, clinics, doctor’s offices and the patient’s home.
I/O Urology Corp.
DCDUFD-001M
In Commercial Distribution

  • 00860010862209 ()


  • Urine flowmeter, reusable
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-128015
In Commercial Distribution

  • 06939698601494 ()
PBCS-128015

  • Neural-tissue balloon catheter
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