Central Monitoring System

GUDID 06944413800229

Edan Instruments, Inc.

Patient monitoring system central station monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor

• Primary Device ID: 06944413800229
• NIH Device Record Key: f9723ee6-bfd2-4041-9d71-4f47f427ed4b
• 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: 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	06944413800229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120727

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [Central Monitoring System]

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