Poiesis Medical L L C

FDA Filings

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

FDA Registration(s)

• Registration Number: 3009425008
• FEI Number: 3009425008
• Name: POIESIS MEDICAL, LLC
• Owner & Operator: Poiesis Medical, LLC
• Contact Address: 1095 Jupiter Park Drive Suite 10; Jupiter FL 33458 US
• Official Correspondent:
  • Charlene Johnson
  • 1-561-8427560-504
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 151 Fern Street Suite 1 ; JUPITER, FL 33458 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 10852732004132 POIESIS MEDICAL, LLC	Duette™	2020-12-04
GUDID 10852732004125 POIESIS MEDICAL, LLC	Duette™	2020-12-04
GUDID 10852732004088 POIESIS MEDICAL, LLC	Duette™	2020-12-04
GUDID 10852732004071 POIESIS MEDICAL, LLC	Duette™	2020-12-04
GUDID 10852732004064 POIESIS MEDICAL, LLC	Duette™	2020-12-04
GUDID 10852732004040 POIESIS MEDICAL, LLC	Duette™	2020-12-04
GUDID 10852732004033 POIESIS MEDICAL, LLC	Duette™	2020-12-04
GUDID 10852732004026 POIESIS MEDICAL, LLC	Duette™	2020-12-04
GUDID 10852732004019 POIESIS MEDICAL, LLC	Duette™	2020-12-04
GUDID 10852732004002 POIESIS MEDICAL, LLC	Duette™	2020-12-04
PMN K173533 Poiesis Medical, LLC	Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter	2018-03-29
GUDID 20852732004047 POIESIS MEDICAL, LLC	Duette™	2018-03-29
PMN K941488 | EZL POIESIS MEDICAL, LLC	Duette? Dual Balloon Catheter	2012-06-15
PMN K941488 | EZL POIESIS MEDICAL, LLC	Duette? Dual Balloon Catheter Kit	2012-06-15

Related Finance Registrations

NCAGE Code	5TNL2	POIESIS MEDICAL, LLC
CAGE Code	5TNL2	POIESIS MEDICAL, LLC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019072212771	Shanghai ,China (Mainland) -> Jacksonville, Florida	FOLEY CATHETERIZATION TRAY	400 CTN
2019042030296	Shanghai ,China (Mainland) -> Los Angeles, California	FOLEY CATHETERIZATION TRAY	675 CTN
2019011515140	Shanghai ,China (Mainland) -> Savannah, Georgia	FOLEY CATHETERIZATION TRAY URINE BAG	285 CTN
201810267039	Shanghai ,China (Mainland) -> Miami, Florida	FOLEY CATHETERIZATION TRAY	726 CTN
201805214950	Shanghai ,China (Mainland) -> Miami, Florida	FOLEY CATHETERIZATION TRAY	36 CTN
201804043351	Yantian,China (Mainland) -> Miami, Florida	DOUBLE BALLOON CATHERER	13 CTN
201802055504	Shanghai ,China (Mainland) -> Miami, Florida	FOLEY CATHETERIZATION TRAY	847 CTN
201801208501	Shanghai ,China (Mainland) -> Miami, Florida	FOLEY CATHETERIZATION TRAY URINE BAG	310 CTN