Aquilex Fluid Control System

GUDID 04056702006914

W.O.M. World of Medicine GmbH

Hysteroscopic irrigation/insufflation system
Primary Device ID04056702006914
NIH Device Record Key28f7593a-5bfc-49a2-b124-9be400aa98d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAquilex Fluid Control System
Version Model NumberAQL-100PBS
Company DUNS316305242
Company NameW.O.M. World of Medicine GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104056702006914 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIGInsufflator, Hysteroscopic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-27
Device Publish Date2018-06-26

Devices Manufactured by W.O.M. World of Medicine GmbH

04056702012861 - GYN-Pump2024-07-08
04056702012878 - Fluid Monitoring Unit2024-07-08
04056702008789 - Heating tube set for insufflation, single use2020-11-09
04056702008802 - Tube set for insufflation, single-use2020-11-09
04056702008826 - Tube set for suction, single-use2020-11-09
04056702008840 - Tube set for suction (with 2 ports), single-use2020-11-09
04056702008864 - Tube set for irrigation, single-use2020-11-09
04056702008888 - Tube set for vacuum incl. filter, 30-day use2020-11-09

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