AccessGUDID - DEVICE: Fluent Fluid Management System (15420045507401)

GUDID

Device Identifier (DI) Information

Brand Name: Fluent Fluid Management System
Version or Model: FLT-112S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FLT-112S
Company Name: Hologic, Inc.

Primary DI Number: 15420045507401
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 018925968 *Terms of Use

Device Description: 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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36122	Hysteroscopic irrigation/insufflation system	A mains electricity (AC-powered) device assembly used during endoscopic procedures of the uterus (i.e., hysteroscopy) to distend (expand by pressure) the uterus by filling the uterine cavity with a liquid to improve visualization (e.g., a hysteroscope) and enlarge the surgical field; it also circulates the fluid to provide irrigation that will remove tissue/debris from the site. This system will typically electronically monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Some distention systems are combined with gynaecologic resectoscopes.	Active	false

FDA Product Code

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Product Code	Product Code Name
HIG	INSUFFLATOR, HYSTEROSCOPIC
HIH	HYSTEROSCOPE (AND ACCESSORIES)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180825	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d7b5f038-95e3-4324-b562-c5094ef8b240
Public Version Date: August 17, 2023
Public Version Number: 2
DI Record Publish Date: August 28, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
35420045507405	1	25420045507408	In Commercial Distribution	BOX
45420045507402	6	25420045507408	In Commercial Distribution	CARTON
25420045507408	1	15420045507401	In Commercial Distribution	BOX