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: P2000 FDA UDI

Identifiers

Primary DI / UDI-DI: 00860936000310 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.

Fluid Monitoring Unit — W.O.M. World of Medicine GmbH · Class II
Hayden Medical — Hayden Medical Inc · Class II
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Thermedx, LLC

Sources (1)

FDA UDI a86bf21c-de52-46f6-9720-a21bbe50a25e 33 fields · synced Jun 1, 2026