Fluid Management System

FDA UDI

Class II (US FDA UDI)

by Thermedx, LLC

Identity

Trade Name: Fluid Management System FDA UDI
Generic Name: Hysteroscopic irrigation/insufflation system FDA UDI
Model / Reference: W2100 FDA UDI

Identifiers

Primary DI / UDI-DI: 00860936000327 FDA UDI
510(k) Number: K091939 FDA UDI
K133799 FDA UDI
FDA Product Code: HRX FDA UDI
LGZ FDA UDI
HIG FDA UDI
GMDN Term: Hysteroscopic irrigation/insufflation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.1100 FDA UDI
880.5725 FDA UDI
884.1700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Hysteroscopic irrigation/insufflation system

Fluid Management System by Thermedx, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hysteroscopic irrigation/insufflation system.

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HysteroBalance II — W.O.M. World of Medicine GmbH · Class II
Fluid Safe — Stryker Corp. · Class II
TRUCLEARTM Calibration Insert 2.9 — Smith & Nephew, Inc. · Class II
Aquilex® Fluid Control System — W.O.M. World of Medicine GmbH · Class II
Premier — PREMIER DENTAL PRODUCTS COMPANY · Class II
TruClear — Covidien LP · Class II

Cleared under the same submission

K091939 also covers:

K133799 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Thermedx, LLC

Sources (1)

FDA UDI 898fa03b-fe61-4ce0-9c1a-d1be50c3938a 33 fields · synced May 30, 2026