Prometra Programmable Pump

GUDID 00810335020082

The Prometra Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter.

Flowonix Medical, Inc.

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• Primary Device ID: 00810335020082
• NIH Device Record Key: e09049d7-8a0f-4939-8708-743af0a54551
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prometra Programmable Pump
• Version Model Number: 11827
• 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
• 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	00810335020082 [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: 4
• Public Version Date: 2018-10-22
• Device Publish Date: 2014-09-24

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