Fluent Pro Waste Bag FLT-205

GUDID 15420045516113

The Fluent Pro 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 liquid flowing into and out of the uterus while providing drive, control, and suction for hysteroscopic morcellators.

Hologic, Inc.

Hysteroscopic irrigation/insufflation system
Primary Device ID15420045516113
NIH Device Record Key883016db-0875-4fb7-8fd9-009efca10d25
Commercial Distribution StatusIn Commercial Distribution
Brand NameFluent Pro Waste Bag
Version Model NumberFLT-205
Catalog NumberFLT-205
Company DUNS018925968
Company NameHologic, Inc.
Device Count5
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com
Phone+1(800)442-9892
EmailCustomerSupport@hologic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045516113 [Unit of Use]
GS125420045516110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIHHYSTEROSCOPE (AND ACCESSORIES)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-23
Device Publish Date2024-10-15

Devices Manufactured by Hologic, Inc.

15420045517097 - DIGITAL DIAGNOSTICS SYSTEM2025-07-25 Computer to operate the Genius™ Review Station.
15420045517851 - Selenia® Dimensions®2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and
15420045517882 - Selenia® Dimensions®2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and
15420045517899 - Selenia® Dimensions®2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and
15420045517905 - Selenia® Dimensions®2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b
15420045517912 - Selenia® Dimensions®2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b
15420045517929 - Selenia® Dimensions®2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b
15420045517936 - Selenia® Dimensions®2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.