Vital Signs Monitor

GUDID 06944413813458

Edan Instruments, Inc.

General-purpose multi-parameter bedside monitor

• Primary Device ID: 06944413813458
• NIH Device Record Key: c7c36c70-898c-4911-a95e-218d96ad5b1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vital Signs Monitor
• Version Model Number: iM3Bs
• 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	06944413813458 [Primary]
GS1	06944413816824 [Package]; Package: [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202892

FDA Product Code

• DQA: Oximeter

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: 2021-02-09
• Device Publish Date: 2021-02-01

On-Brand Devices [Vital Signs Monitor]

• 06944413808812: iM3
• 06944413807808: MM3
• 06944413807716: VSM-300B
• 06944413806689: VSM-300A
• 06944413806672: VSM-300
• 06944413800786: M3A
• 06944413800625: M3B
• 06944413800618: M3
• 06944413813465: iHM3s
• 06944413813458: iM3Bs
• 06944413813441: iM3As
• 06944413811171: iM3s