Patient Monitor

GUDID 06944413838406

Edan Instruments, Inc.

General-purpose multi-parameter bedside monitor

• Primary Device ID: 06944413838406
• NIH Device Record Key: 75695f56-a490-4517-8d76-4391ca638a9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Monitor
• Version Model Number: CX10
• Company DUNS: 529173163
• Company Name: Edan Instruments, Inc.
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944413838406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250179

FDA Product Code

• CCL: Analyzer, Gas, Oxygen, Gaseous-Phase

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: 2025-09-15
• Device Publish Date: 2025-09-05

On-Brand Devices [Patient Monitor ]

• 06944413808119: PM-2000A+
• 06944413806726: PM-2000M
• 06944413806696: MM17
• 06944413806665: PM-2000XL Plus
• 06944413806658: PM-2000XL
• 06944413806641: PM-2000XL Pro
• 06944413806634: PM-2000A Pro
• 06944413806627: PM-2000A
• 06944413802179: iM20
• 06944413802162: elite V6
• 06944413802155: elite V5
• 06944413801844: iM70
• 06944413801837: iM60
• 06944413801707: elite V8
• 06944413801646: iM80
• 06944413801622: iM50
• 06944413801615: iM8B
• 06944413801608: iM8A
• 06944413801592: iM8
• 06944413800823: M50
• 06944413800816: M80
• 06944413810945: X12
• 06944413810921: X10
• 06944413810907: X8
• 06944413814769: X12s
• 06944413814752: X8s
• 06944413814387: X10s
• 06944413815902: iX15
• 06944413815896: iX12
• 06944413815889: iX10
• 06944413838451: UX15
• 06944413838444: UX12
• 06944413838437: UX10
• 06944413838420: CX15
• 06944413838413: CX12
• 06944413838406: CX10