Fluent Fluid Management System FLT-005

GUDID 45420045507662

The Fluent Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus while providing drive, control and suction for hysteroscopic morcellators

Hologic, Inc.

Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system Hysteroscopic irrigation/insufflation system

• Primary Device ID: 45420045507662
• NIH Device Record Key: 3c4159d1-69f9-4bc2-a6ae-15797bafbc2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fluent Fluid Management System
• Version Model Number: FLT-005
• Catalog Number: FLT-005
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 5
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045507661 [Unit of Use]
GS1	25420045507668 [Primary]
GS1	35420045507665 [Package]; Contains: 25420045507668; Package: BOX [1 Units]; In Commercial Distribution
GS1	45420045507662 [Package]; Contains: 35420045507665; Package: CARTON [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180825

FDA Product Code

• HIH: HYSTEROSCOPE (AND ACCESSORIES)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-27
• Device Publish Date: 2023-12-19

On-Brand Devices [Fluent Fluid Management System]

• 15420045507401: FLT-112S
• 45420045507662: The Fluent Fluid Management System is intended to provide liquid distension of the uterus during
• 45420045505279: The Fluent Fluid Management System is intended to provide liquid distension of the uterus during