Patient Monitor

GUDID 06944413800816

Edan Instruments, Inc.

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 06944413800816
• NIH Device Record Key: 9f6138c3-63a9-4a7a-94c3-16b4260c8fea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Monitor
• Version Model Number: M80
• 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	06944413800816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110922

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: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2016-09-01

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