Prometra Patient Therapy Controller

GUDID 00810335020174

The Patient Therapy Controller (PTC) is a handheld touchscreen device, which allows a patient to initiate a pre-configured supplemental bolus of medication from their implanted Programmable Pump. The patient requests a bolus by pressing the Rx button on the PTC and then placing it over their implanted pump. The Patient Therapy Controller communicates with the implanted pump initiating the supplemental bolus delivery. The settings for the bolus delivery are programmed into the Patient Therapy Controller by a healthcare certified professional (HCP) using the Configuration Device.

Flowonix Medical, Inc.

Infusion pump programmer
Primary Device ID00810335020174
NIH Device Record Keycb64da1a-48a4-49ed-876d-5d904c7e127c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrometra Patient Therapy Controller
Version Model Number12860
Company DUNS013518517
Company NameFlowonix Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not get wet
Special Storage Condition, SpecifyBetween 0 and 0 *Do not get wet

Device Identifiers

Device Issuing AgencyDevice ID
GS100810335020174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKKPump, Infusion, Implanted, Programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-08-24

Devices Manufactured by Flowonix Medical, Inc.

00810335020242 - Prometra Programmable Pump2024-04-03 Prometra II 40ml Programmable Pump
00810335020082 - Prometra Programmable Pump2018-10-22 The Prometra Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a r
00810335020228 - Prometra II Pump2018-10-22 The Prometra II Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with
00810335020099 - Prometra Intrathecal Catheter2018-07-06 The Intrathecal Catheter is a sterile, single-piece, radiopaque, silicone catheter with a pre-inserted hydrophilic stiffening st
00810335020105 - Prometra Catheter Revision Kit2018-07-06 The Catheter Revision Kit is a sterile kit designed to facilitate the replacement of a section of the intrathecal catheter. A r
00810335020129 - Prometra Programmer2018-07-06 The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted pump that enables remote program
00810335020136 - Prometra Catheter Access Kit2018-07-06 The Catheter Access Kit is sterile and provides the components and instructions necessary to access the catheter access port of
00810335020143 - Prometra Refill Kit2018-07-06 The Refill Kit is sterile and provides the components and instructions necessary to access the pump reservoir to empty and fill

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.