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