Fluent Fluid Management System
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Fluent Fluid Management System Disposable Procedure Kit EUDAMEDFluent Fluid Management System FDA UDI
- Generic Name
- Hysteroscopic irrigation/insufflation system FDA UDI
- Device Name
- Fluent Fluid Management System Disposable Procedure Kit EUDAMEDThe 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 FDA UDI
- Model / Reference
- FLT-112S EUDAMEDFDA UDI
- 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 FDA UDI
Identifiers
- Catalog Number
- FLT-112S FDA UDI
- Primary DI / UDI-DI
- 15420045507401 EUDAMEDFDA UDI
- Basic UDI-DI
- B-15420045507401 EUDAMED
- 510(k) Number
- K180825 FDA UDI
- FDA Product Code
- HIG FDA UDIHIH FDA UDI
- EMDN Code
- A080201 INFUSION PUMP BAGS AND CONTAINERS, SINGLE-USE EUDAMED
- GMDN Term
- Hysteroscopic irrigation/insufflation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1700 FDA UDI884.1690 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Hysteroscopic irrigation/insufflation system
Fluent Fluid Management System by Hologic, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (2)
- FDA UDI d7b5f038-95e3-4324-b562-c5094ef8b240 36 fields · synced Jun 20, 2026
- EUDAMED f1299fe8-b887-4a75-8deb-06512dbae9ef 61 fields · synced Jun 20, 2026