Prometra II Pump

GUDID 00810335020228

The Prometra II Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter. To help increase safety, the Prometra II Pump incorporates a safety valve (flow-activated valve or FAV) that will shut off drug flow to the patient in the event a high flow rate occurs, such as during an MRI. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer. The Prometra II Pump contains a metal bellows drug reservoir with a capacity of 20 milliliters (mL). The reservoir propellant is stored within the rigid housing surrounding the bellows and provides the driving pressure for the pump. The driving pressure on the reservoir forces the infusate through an outlet filter (0.22 pm), and into an electronically controlled flow metering valve-accumulator subsystem. The Infumorph passes from the flow metering subsystem, into the catheter access port then into the catheter for delivery to the intrathecal space.

Flowonix Medical, Inc.

Implantable intrathecal infusion pump, programmable
Primary Device ID00810335020228
NIH Device Record Keyacd6019a-7200-487f-87ba-90b86c83856c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrometra II Pump
Version Model Number13827
Company DUNS013518517
Company NameFlowonix Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 52 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810335020228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKKPump, Infusion, Implanted, Programmable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-22
Device Publish Date2015-04-29

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 Pump2018-10-22The Prometra II Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter. To help increase safety, the Prometra II Pump incorporates a safety valve (flow-activated valve or FAV) that will shut off drug flow to the patient in the event a high flow rate occurs, such as during an MRI. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer. The Prometra II Pump contains a metal bellows drug reservoir with a capacity of 20 milliliters (mL). The reservoir propellant is stored within the rigid housing surrounding the bellows and provides the driving pressure for the pump. The driving pressure on the reservoir forces the infusate through an outlet filter (0.22 pm), and into an electronically controlled flow metering valve-accumulator subsystem. The Infumorph passes from the flow metering subsystem, into the catheter access port then into the catheter for delivery to the intrathecal space.
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
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