Prometra Patient Therapy Controller

GUDID 00810335020174

The Patient Therapy Controller (PTC) is a handheld touchscreen device, which allows a patient to initiate a pre-configured supplemental bolus of medication from their implanted Programmable Pump. The patient requests a bolus by pressing the Rx button on the PTC and then placing it over their implanted pump. The Patient Therapy Controller communicates with the implanted pump initiating the supplemental bolus delivery. The settings for the bolus delivery are programmed into the Patient Therapy Controller by a healthcare certified professional (HCP) using the Configuration Device.

Flowonix Medical, Inc.

Infusion pump programmer

• Primary Device ID: 00810335020174
• NIH Device Record Key: cb64da1a-48a4-49ed-876d-5d904c7e127c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prometra Patient Therapy Controller
• Version Model Number: 12860
• Company DUNS: 013518517
• Company Name: Flowonix Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not get wet
• Special Storage Condition, Specify: Between 0 and 0 *Do not get wet

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810335020174 [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: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-24

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