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 Infusion pump programmer

• Primary Device ID: 00810335020129
• NIH Device Record Key: 623afc38-49b9-437c-9bea-4da9b8cd7576
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prometra Programmer
• Version Model Number: 11828
• 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: true
• Serial Number: true
• Manufacturing Date: false
• 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	00810335020129 [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: 2014-09-24

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