Fluid Management System

GUDID 00860936000327

THERMEDX, LLC

Hysteroscopic irrigation/insufflation system

• Primary Device ID: 00860936000327
• NIH Device Record Key: 898fa03b-fe61-4ce0-9c1a-d1be50c3938a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fluid Management System
• Version Model Number: W2100
• Company DUNS: 022465035
• Company Name: THERMEDX, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860936000327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091939

FDA Product Code

• HRX: Arthroscope

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: 2016-09-23

On-Brand Devices [Fluid Management System]

• 00860936000327: W2100
• 00860936000310: P2000