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 ID: 00810335020167
• NIH Device Record Key: d385c0fd-c2c9-4703-9930-fba279e7c809
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prometra Programmer
• Version Model Number: 12828
• 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	00810335020167 [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: 2015-04-29

On-Brand Devices [Prometra Programmer]

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