Central Monitoring System

GUDID 06944413814264

Edan Instruments, Inc.

Centralized patient monitor

• Primary Device ID: 06944413814264
• NIH Device Record Key: 32aae3b3-d3be-4511-bbc1-8107e8a084b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Central Monitoring System
• Version Model Number: MFM-CMS
• Company DUNS: 529173163
• Company Name: Edan Instruments, Inc.
• 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: true
• Serial Number: false
• 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	06944413814264 [Primary]
GS1	06944413839649 [Package]; Package: [1 Units]; Discontinued: 2024-06-18; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232694

FDA Product Code

• MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-29
• Device Publish Date: 2024-04-19

On-Brand Devices [Central Monitoring System]

• 06944413807983: MFM-CNS Lite
• 06944413806825: CMS-1000FM
• 06944413800236: MFM-CNS
• 06944413800229: MFM-CMS
• 06944413814264: MFM-CMS