HysteroLux™ Fluid Management System Control Unit

GUDID 04056702005672

W.O.M. World of Medicine GmbH

Hysteroscopic irrigation/insufflation system

• Primary Device ID: 04056702005672
• NIH Device Record Key: 74c9879c-011c-48e5-b04b-ecb9131691e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HysteroLux™ Fluid Management System Control Unit
• Version Model Number: PH304
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056702005672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173489

FDA Product Code

• HIG: Insufflator, Hysteroscopic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-18

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

• 04056702012861 - GYN-Pump: 2024-07-08
• 04056702012878 - Fluid Monitoring Unit: 2024-07-08
• 04056702008789 - Heating tube set for insufflation, single use: 2020-11-09
• 04056702008802 - Tube set for insufflation, single-use: 2020-11-09
• 04056702008826 - Tube set for suction, single-use: 2020-11-09
• 04056702008840 - Tube set for suction (with 2 ports), single-use: 2020-11-09
• 04056702008864 - Tube set for irrigation, single-use: 2020-11-09
• 04056702008888 - Tube set for vacuum incl. filter, 30-day use: 2020-11-09