Optimum Medical

FDA Filings

This page includes the latest FDA filings for Optimum Medical. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3009086335
• FEI Number: 3009086335
• Name: Judy K Burton
• Owner & Operator: Optimum Medical
• Contact Address: Tennant Hall Bleinheim Grove; West Yorkshire GB-LDS Leeds LS2 9ET GB
• US Agent:
  • Judy K Burton
  • Advena USA, LLC
  • 972 2435105
  • judy.burton@advenausa.com
• Importing Logistics Registration:
  • Importer: Amazon.com.dedc LLC
  • Address: 3350 Laurel Ridge Avenue ; Ruskin, FL 33570 UNITED STATES
  • Importer Type: RETAILER
• Importing Logistics Registration:
  • Importer: Amazon.com.dedc, Inc.
  • Address: 875 Allen Road ; Carlisle, PA 17015 UNITED STATES
  • Importer Type: RETAILER
• Importing Logistics Registration:
  • Importer: Golden State FC LLC
  • Address: 1555 N. Chrisman Road ; Tracy, CA 95304 UNITED STATES
  • Importer Type: RETAILER
• Importing Logistics Registration:
  • Importer: MDW2
  • Address: 250 Emerald Drive ; Joliet, IL 60433 UNITED STATES
  • Importer Type: RETAILER
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3010 LBJ Frwy 12th Floor; Dallas, TX 75234 US
• Establishment Type:
  • Export Device to the United States But Perform No Other Operation on Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Foreign Private Label Distributor

FDA Filings

Device Company	Device	Date
MSH Judy K Burton [Optimum Medical]	OptiPro N95/FFP2 Particulate Respirator Face Masks	2020-04-15
FXX Judy K Burton [Optimum Medical]	OptiPro 3-ply face masks	2020-04-15
NNY Judy K Burton [Optimum Medical]	Sheath (Male External Catheters)	2019-09-24
NNZ Judy K Burton [Optimum Medical]	Ugo Stand with Dignity	2018-01-17
NNZ Judy K Burton [Optimum Medical]	Ugo Hanger (Drainage Bag Holder)	2018-01-17
NNZ Judy K Burton [Optimum Medical]	Ugo Fix Sleeve	2018-01-17
NNZ Judy K Burton [Optimum Medical]	Ugo Fix Catheter Strap	2018-01-17
NNZ Judy K Burton [Optimum Medical]	Ugo Fix Bag Belt	2018-01-17
NNZ Judy K Burton [Optimum Medical]	Ugo Drainage Leg Bags	2018-01-17
NNZ Judy K Burton [Optimum Medical]	Ugo 2L Drainage Bags	2018-01-17
NNZ Judy K Burton [Optimum Medical]	Multi Fix Gentle	2018-01-17
EYZ Judy K Burton [Optimum Medical]	Ugo Fix Catheter Strap	2018-01-17
EYZ Judy K Burton [Optimum Medical]	Ugo Fix Catheter Clip	2018-01-17
EYZ Judy K Burton [Optimum Medical]	Ugo Catheter Valve	2018-01-17
PMN K112110 | KMJ Judy K Burton [Optimum Medical]	OptiLube	2012-06-19