Fluent Pro Fluid Management System FLT-200

GUDID 15420045516212

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 ID15420045516212
NIH Device Record Keya9ee74af-56b0-4117-a692-d0cc6aa91af6
Commercial Distribution StatusIn Commercial Distribution
Brand NameFluent Pro Fluid Management System
Version Model NumberFLT-200
Catalog NumberFLT-200
Company DUNS018925968
Company NameHologic, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
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

Operating and Storage Conditions

Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045516212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIGInsufflator, hysteroscopic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-14
Device Publish Date2024-08-06

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