Patient Monitor

GUDID 06944413815902

Edan Instruments, Inc.

General-purpose multi-parameter bedside monitor

• Primary Device ID: 06944413815902
• NIH Device Record Key: 92e29afc-71f6-4974-b335-541d4af50c41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Monitor
• Version Model Number: iX15
• 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	06944413815902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232962

FDA Product Code

• BZQ: Monitor, Breathing Frequency

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: 2024-06-25
• Device Publish Date: 2024-06-17

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