Prometra Tunneler

GUDID 00810335020150

The Tunneler is used for subcutaneous placement of the Intrathecal Catheter. It is a sterile, malleable stainless steel tunneler with a pointed tip to penetrate subcutaneous tissue and a threaded end for attachment to the Intrathecal Catheter.

Flowonix Medical, Inc.

Subcutaneous tunneller, single-use
Primary Device ID00810335020150
NIH Device Record Key0b556488-4fd4-4a77-b903-53e8de9a18c6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrometra Tunneler
Version Model Number11826
Company DUNS013518517
Company NameFlowonix Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810335020150 [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 Number3
Public Version Date2018-07-06
Device Publish Date2014-09-24

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

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