Xandar Kardian Monitoring Sensor XK300-H

Primary DI
08809988780018
Brand
Xandar Kardian Monitoring Sensor XK300-H
Company
Xandar Kardian Korea Inc.
Model
XK300-H
Published
2024-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
SBOBed-Patient Activity Monitoring System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SBOBed-Patient Activity Monitoring SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809988780018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809988780018088099887800188809988780018

GMDN Terms#

Term, Definition table
TermDefinition
Contactless patient status monitorAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-833-695-2677support@xkcorp.com

Regulatory Flags#

DUNS number
695005778
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809988780049Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300-E)XK300-E2025-12-04
08809988780001Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300)XK3002024-01-19