Prometra Programmer

GUDID 00810335020129

The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted pump that enables remote programming of the Prometra pump.

Flowonix Medical, Inc.

Infusion pump programmer
Primary Device ID00810335020129
NIH Device Record Key623afc38-49b9-437c-9bea-4da9b8cd7576
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrometra Programmer
Version Model Number11828
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 Batchtrue
Serial Numbertrue
Manufacturing Datefalse
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
GS100810335020129 [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 Date2014-09-24

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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