Flowonix Medical Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 3010079947
• FEI Number: 3010079947
• Name: FLOWONIX MEDICAL, INC.
• Owner & Operator: Flowonix Medical, Inc.
• Contact Address: 500 International Drive Suite 200; Mount Olive NJ 07828 US
• Official Correspondent:
  • Karen Matis
  • x-973-4269229-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 120 Forbes Blvd Suite 170 ; Mansfield, MA 02048 US
• Establishment Type: Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
GUDID 00810335020242 Flowonix Medical, Inc.	Prometra Programmable Pump	2024-04-03
PMA P080012S069 FLOWONIX MEDICAL, INC.	Prometra Programmable Infusion Pump System	2021-03-02
PMA P080012S067 FLOWONIX MEDICAL, INC.	Prometra Programmable Infusion Pump System	2020-10-29
PMA P080012S065 FLOWONIX MEDICAL, INC.	Prometra II Programmable Infusion Pump System	2020-03-17
PMA P080012S064 FLOWONIX MEDICAL, INC.	Prometra Programmable Infusion Pump System	2020-01-15
PMA P080012S062 FLOWONIX MEDICAL, INC.	Prometra Programmable Infusion Pump System, Pump Firmware Patch 0.28	2019-10-22
PMA P080012S060 FLOWONIX MEDICAL, INC.	Prometra Programmable Infusion Pump System	2019-09-23
PMA P080012S059 FLOWONIX MEDICAL, INC.	Prometra II Programmable Infusuin Pump System	2019-08-07
PMA P080012S058 FLOWONIX MEDICAL, INC.	Prometra Programmable Infusion Pump System	2019-07-03
PMA P080012S055 FLOWONIX MEDICAL, INC.	Prometra Programmable Infusion Pump System	2019-03-07
PMA P080012S050 FLOWONIX MEDICAL, INC.	Prometra Programmable Infusion Pump System	2019-01-31
PMA P080012S040 FLOWONIX MEDICAL, INC.	Prometra Programmable Infusion Pump System	2019-01-28
PMA P080012S053 FLOWONIX MEDICAL, INC.	Prometra Programmable Infusion Pump System	2018-12-17
GUDID 00810335020228 Flowonix Medical, Inc.	Prometra II Pump	2018-10-22
GUDID 00810335020082 Flowonix Medical, Inc.	Prometra Programmable Pump	2018-10-22
PMA P080012S051 FLOWONIX MEDICAL, INC.	Prometra Programmable Infusion Pump System	2018-08-17
GUDID 00810335020181 Flowonix Medical, Inc.	Prometra Physician Configuration Device	2018-07-06
GUDID 00810335020174 Flowonix Medical, Inc.	Prometra Patient Therapy Controller	2018-07-06
GUDID 00810335020167 Flowonix Medical, Inc.	Prometra Programmer	2018-07-06
GUDID 00810335020150 Flowonix Medical, Inc.	Prometra Tunneler	2018-07-06
GUDID 00810335020143 Flowonix Medical, Inc.	Prometra Refill Kit	2018-07-06
GUDID 00810335020136 Flowonix Medical, Inc.	Prometra Catheter Access Kit	2018-07-06
GUDID 00810335020129 Flowonix Medical, Inc.	Prometra Programmer	2018-07-06
GUDID 00810335020105 Flowonix Medical, Inc.	Prometra Catheter Revision Kit	2018-07-06
GUDID 00810335020099 Flowonix Medical, Inc.	Prometra Intrathecal Catheter	2018-07-06
PMA P080012S047 FLOWONIX MEDICAL, INC.	Prometra Programmable Implantable Pump / Prometra II Programmable Implantable Pump	2017-12-19
PMA P080012S046 FLOWONIX MEDICAL, INC.	Prometra Programmable Infusion Pump System	2017-09-11
PMA P080012S045 FLOWONIX MEDICAL, INC.	Prometra Programmable Infusion Pump System	2017-08-21
PMA P080012S042 FLOWONIX MEDICAL, INC.	Prometra Programmable Infusion Pump System	2017-07-21
PMA P080012S044 FLOWONIX MEDICAL, INC.	Prometra Programmable Infusion Pump System	2017-06-29
PMA P080012S043 FLOWONIX MEDICAL, INC.	Prometra Programmable Infusion Pump System	2017-06-07
PMA P080012S041 FLOWONIX MEDICAL, INC.	Prometra Programmable Infusion Pump System	2017-05-31
PMA P080012S036 FLOWONIX MEDICAL, INC.	PROMETRA PATIENT THERAPY CONTROLLER	2017-03-31
PMA P080012S039 FLOWONIX MEDICAL, INC.	Prometra Programmable Infusion Pump System	2017-03-30
PMA P080012S037 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM CLINICIAN PROGRAMMER	2016-12-16
PMA P080012S035 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE IMPLANTABLE PUMP	2016-08-31
PMA P080012S033 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM	2016-05-26
PMA P080012S030 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM	2016-01-12
PMA P080012S031 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE PUMP SYSTEM	2015-12-28
PMA P080012S032 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE IMPLANTABLE PUMP	2015-11-24
PMA P080012S029 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE IMPLANTABLE PUMP	2015-09-01
PMA P080012S028 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE IMPLANTABLE PUMP	2015-07-31
PMA P080012S023 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM	2015-07-29
PMA P080012S025 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM	2015-04-08
PMA P080012S024 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM	2015-02-12
PMA P080012S021 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM	2015-02-10
PMA P080012S022 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM	2014-12-18
PMA P080012S020 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM	2014-05-22
PMA P080012S019 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM	2014-02-04
PMA P080012S016 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE IMPLANTABLE PUMP	2013-07-02
PMA P080012S018 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM	2013-06-24
PMA P080012S013 FLOWONIX MEDICAL, INC.	PROMERA PROGRAMMABLE INFUSION PUMP SYSTEM	2013-06-03
PMA P080012S017 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE IMPLANTABLE PUMP	2013-05-16
PMA P080012S012 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM	2013-04-19
PMA P080012S014 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM	2013-04-09
PMA P080012S011 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM	2013-04-09
PMA P080012S004 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM	2013-02-13
PMA P080012S010 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM	2013-01-22
PMA P080012S009 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE IMPLANTABLE PUMP, 1031200	2012-11-06
PMA P080012S006 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM	2012-09-13
PMA P080012S007 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE IMPLANTABLE PUMP, 1031200	2012-09-11
PMA P080012S003 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM	2012-05-04
PMA P080012S002 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM	2012-05-04
PMA P080012S001 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM	2012-05-03
PMN P080012 | LKK FLOWONIX MEDICAL, INC.	Prometra	2012-02-23
PMA P080012 FLOWONIX MEDICAL, INC.	PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM	2012-02-07

Similar & Related FDA Registered Companies

• FLOWONIX MEDICAL, INC.500 International Drivesuite 200mt.olive, NJ 07828 PMA NumberP080012 Supplement NumberS072 Date Received03/30/2022 Decision Date04/28/2022 Product Code LKK  Advisory Committee General Hospital Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	61GA5	FLOWONIX MEDICAL, INC.!DBA FLOWONIX MEDICAL
CAGE Code	61GA5	FLOWONIX MEDICAL, INC. FLOWONIX MEDICAL
SEC	0001386879	Flowonix Medical Inc of DELAWARE