Prometra Programmable Pump

GUDID 00810335020242

Prometra II 40ml Programmable Pump

Flowonix Medical, Inc.

Implantable intrathecal infusion pump, programmable

• Primary Device ID: 00810335020242
• NIH Device Record Key: dd6d66c4-9a5f-4a8d-bb77-28547ce07c58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prometra Programmable Pump
• Version Model Number: 16827
• Company DUNS: 013518517
• Company Name: Flowonix Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 52 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810335020242 [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: 2
• Public Version Date: 2024-04-03
• Device Publish Date: 2020-06-05

On-Brand Devices [Prometra Programmable Pump]

• 00810335020082: The Prometra Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, prog
• 00810335020242: Prometra II 40ml Programmable Pump