Xandar Kardian Monitoring Sensor XK300-H

Basic Information

• Brand Name: Xandar Kardian Monitoring Sensor XK300-H
• Primary DI: 08809988780018
• Version / Model: XK300-H
• Company Name: Xandar Kardian Korea Inc.
• Labeler DUNS: 695005778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-31
• Public Version: 1
• Public Version Date: 2024-08-08
• Public Version Status: New
• Public Device Record Key: b8a8d95f-08f2-4d17-876e-64213e5eb6b7

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SBO	Bed-Patient Activity Monitoring System	General Hospital	880.2400	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66918	Contactless patient status monitor	An electronic device designed for professional use in a clinical or homecare setting for contactless intermittent assessment or continuous monitoring of pulse and respiration rates, and bed exit/occupancy, of a patient during rest or mild body movement. It consists of a small unit, similar to a motion sensor, which uses radar-based micro-motion detection from a close distance (<=5ft) [i.e., non-patient-contact] and has integrated interpretive software algorithms to measure and communicate data to a web-based cloud platform for display at a remote centralized patient monitor.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809988780018	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]