Fluent Fluid Management System Tissue Trap
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Identity
- Trade Name
- Fluent Fluid Management System Tissue Trap EUDAMEDFluent Fluid Management System FDA UDI
- Generic Name
- Hysteroscopic irrigation/insufflation system FDA UDI
- Device Name
- Fluent Fluid Management System Waste Bag; Fluent Fluid Management System Tissue Trap; Fluent Pro Fluid Management System Waste Bag; Fluent Pro Fluid Management System Tissue Trap 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-010 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-010 FDA UDI
- Primary DI / UDI-DI
- 25420045505275 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455GSSFLUENTMULTIH7 EUDAMED
- Unit of Use DI
- 15420045505278 EUDAMED
- 510(k) Number
- K180825 FDA UDI
- FDA Product Code
- HIG FDA UDIHIH FDA UDI
- EMDN Code
- A080299 INFUSION BAGS AND CONTAINERS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Hysteroscopic irrigation/insufflation system FDA UDI
Classification
- Device Class
- Class I 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
No
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: Intravenous administration bag/bottle
Fluent Fluid Management System Tissue Trap by Hologic Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180825 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 54200455GSSFLUENTMULTIH7 | Class I | Active |
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Manufacturer
- Manufacturer
- Hologic, Inc.
- EUDAMED SRN
- US-MF-000003310
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (3)
- EUDAMED 8a6ebabc-b29f-41a3-9a83-09fb9513b381 61 fields · synced Jul 27, 2026
- FDA UDI b7ed356a-f807-4fe8-bd18-3aa9d14ed0f3 36 fields · synced May 30, 2026
- FDA 510(k) K180825 1 fields · synced May 18, 2026