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 ID: 00810335020150
• NIH Device Record Key: 0b556488-4fd4-4a77-b903-53e8de9a18c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prometra Tunneler
• Version Model Number: 11826
• Company DUNS: 013518517
• Company Name: Flowonix Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810335020150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080012

FDA Product Code

• LKK: Pump, Infusion, Implanted, Programmable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-24

Devices Manufactured by Flowonix Medical, Inc.

• 00810335020242 - Prometra Programmable Pump: 2024-04-03 Prometra II 40ml Programmable Pump
• 00810335020082 - Prometra Programmable Pump: 2018-10-22 The Prometra Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a r
• 00810335020228 - Prometra II Pump: 2018-10-22 The Prometra II Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with
• 00810335020099 - Prometra Intrathecal Catheter: 2018-07-06 The Intrathecal Catheter is a sterile, single-piece, radiopaque, silicone catheter with a pre-inserted hydrophilic stiffening st
• 00810335020105 - Prometra Catheter Revision Kit: 2018-07-06 The Catheter Revision Kit is a sterile kit designed to facilitate the replacement of a section of the intrathecal catheter. A r
• 00810335020129 - Prometra Programmer: 2018-07-06 The Prometra Programmer is a non-sterile handheld menu driven device, external to the implanted pump that enables remote program
• 00810335020136 - Prometra Catheter Access Kit: 2018-07-06 The Catheter Access Kit is sterile and provides the components and instructions necessary to access the catheter access port of
• 00810335020143 - Prometra Refill Kit: 2018-07-06 The Refill Kit is sterile and provides the components and instructions necessary to access the pump reservoir to empty and fill