Fluent™ inflation device

GUDID M20682510

The Fluent inflation device kit and components are to be used to facilitate the use of guidewires, catheters, balloons, and other interventional devices during angioplasty procedures. Model 8251 contains Fluent inflation device, stopcock and torque device.

Vascular Solutions, Inc.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: M20682510
• NIH Device Record Key: e4f23b9c-98d4-46eb-80f8-3b7426a9f643
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fluent™ inflation device
• Version Model Number: 8251
• Company DUNS: 008999906
• Company Name: Vascular Solutions, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M20682510 [Primary]

FDA Product Code

• MAV: Syringe, Balloon Inflation

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: 2020-05-06
• Device Publish Date: 2018-09-24

On-Brand Devices [Fluent™ inflation device]

• M20682590: The Fluent inflation device kit and components are to be used to facilitate the use of guidewire
• M20682580: The Fluent inflation device kit and components are to be used to facilitate the use of guidewire
• M20682570: The Fluent inflation device kit and components are to be used to facilitate the use of guidewire
• M20682560: The Fluent inflation device kit and components are to be used to facilitate the use of guidewire
• M20682550: The Fluent inflation device kit and components are to be used to facilitate the use of guidewire
• M20682540: The Fluent inflation device kit and components are to be used to facilitate the use of guidewire
• M20682530: The Fluent inflation device kit and components are to be used to facilitate the use of guidewire
• M20682520: The Fluent inflation device kit and components are to be used to facilitate the use of guidewire
• M20682510: The Fluent inflation device kit and components are to be used to facilitate the use of guidewire
• M20682500: The Fluent inflation device kit and components are to be used to facilitate the use of guidewire