Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300)

GUDID 08809988780001

Xandar Kardian Korea Inc.

Multiple vital physiological parameter monitoring system, home-use

• Primary Device ID: 08809988780001
• NIH Device Record Key: a78f7726-8ef6-4e8a-8283-20f8f76e413f
• Commercial Distribution Discontinuation: 2024-01-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300)
• Version Model Number: XK300
• Company DUNS: 695005778
• Company Name: Xandar Kardian Korea Inc.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809988780001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202464

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: 2024-01-29
• Device Publish Date: 2024-01-19

Devices Manufactured by Xandar Kardian Korea Inc.

• 08809988780018 - Xandar Kardian Monitoring Sensor XK300-H: 2024-08-08
• 08809988780001 - Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300): 2024-01-29
• 08809988780001 - Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300): 2024-01-29