Prometra Programmer

GUDID 00810335020167

The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted pump that enables remote programming of the implantable Programmable Pump using a touchscreen interface. The Programmer can program the pump to deliver a precise flow of medication at a constant or variable rate, or it can be set to periodically deliver a drug dosage at distinct intervals of time (i.e., Periodic Flow Mode). There is also an option to interrupt the pump's current medication regimen and deliver an immediate infusion of medication (Demand Bolus).

Flowonix Medical, Inc.

Infusion pump programmer
Primary Device ID00810335020167
NIH Device Record Keyd385c0fd-c2c9-4703-9930-fba279e7c809
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrometra Programmer
Version Model Number12828
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
GS100810335020167 [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 Date2015-04-29

On-Brand Devices [Prometra Programmer]

00810335020167The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted
00810335020129The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted

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