Aquilex® Fluid Control System

GUDID 04056702002145

W.O.M. World of Medicine GmbH

Hysteroscopic irrigation/insufflation system

• Primary Device ID: 04056702002145
• NIH Device Record Key: 4cf3ff86-86e2-4e2d-bd7a-5f79dd2c0582
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aquilex® Fluid Control System
• Version Model Number: AQL-100CS
• Company DUNS: 316305242
• Company Name: W.O.M. World of Medicine GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056702002145 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112642

FDA Product Code

• HIG: Insufflator, Hysteroscopic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-10

On-Brand Devices [Aquilex® Fluid Control System]

• 04056702006556: AQL-100CBS
• 04056702002145: AQL-100CS
• 04056702002121: AQL-100P