Fluid Management System

GUDID 00860936000327

THERMEDX, LLC

Hysteroscopic irrigation/insufflation system
Primary Device ID00860936000327
NIH Device Record Key898fa03b-fe61-4ce0-9c1a-d1be50c3938a
Commercial Distribution StatusIn Commercial Distribution
Brand NameFluid Management System
Version Model NumberW2100
Company DUNS022465035
Company NameTHERMEDX, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860936000327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [Fluid Management System]

00860936000327W2100
00860936000310P2000

Trademark Results [Fluid Management System]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FLUID MANAGEMENT SYSTEM
FLUID MANAGEMENT SYSTEM
74202113 not registered Dead/Abandoned
SANNING, FRANK B.
1991-09-09

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