Fluid Monitoring Unit

GUDID 04056702005689

W.O.M. World of Medicine GmbH

Hysteroscopic irrigation/insufflation system

• Primary Device ID: 04056702005689
• NIH Device Record Key: c8f7fade-cfab-45af-a66b-248a910eeb63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fluid Monitoring Unit
• Version Model Number: PS304
• 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	04056702005689 [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: 2018-04-16

On-Brand Devices [Fluid Monitoring Unit]

• 04056702005689: PS304
• 04056702012878: PS304