HEALTHTRUST UNIVERSITY CONFERENCE

GENICON, upon invitation by HealthTrust Purchasing Group (HPG), proudly exhibited the GENIStrong and SimplyStrong products at the Healthtrust University Conference  within San Antonio, Texas on August 29th and 30th.  Several hospital groups within the HPG network sought out the specimen retrieval technologies that reside within GENICON’s product offering, recognizing the value of the award winning design and competitive pricing.  Our appreciation is extended to the leadership of HPG for inviting our growing Company to attend, as well as providing a venue that facilitated the Company’s ability to demonstrate its value proposition to HPG membership.

img_0402

GENICON, Inc. Announces Compliance with FDA’s – Unique Device Identification (UDI) and Global Unique Device Identification Database (GUDID) Requirements.

ucm444798

Global Unique Device Identification Database (GUDID) Requirements.

 

Winter Park, FL – August 30, 2016 – GENICON, a U.S. medical device company, has met the requirements for the Food and Drug Administration (FDA) Unique Device Identification (UDI) Final Rule for device labeling and published the required information into the FDA’s Global Unique Device Identification Database (GUDID). This system will be utilized to adequately identify medical devices through their distribution and use.

When fully implemented, the Unique Device Identification System will offer a range of benefits to industry, FDA, consumers, health care providers and health care systems by some of the following objectives:

  • Facilitate the accurate identification of a device using the UDI that appears on the device’s label and device package.
  • Be able to easily access important information concerning the device.
  • Allow more accurate reporting, reviewing, and analyzing of adverse event reports so that problems can be identified and corrected more quickly.
  • Provide a standard and clear way to document device use in electronic health records, clinical information systems, claims data sources and registries, leading to a more robust postmarket surveillance system which can be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.
  • Enable manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
  • Provide a foundation for a global, secure distribution chain that will help address counterfeiting and diversion, and prepare for medical emergencies.
  • Lead to the development of a medical device identification system that is recognized around the world.