Xandar Kardian Monitoring Sensor XK300-H

GUDID 08809988780018

Xandar Kardian Korea Inc.

Contactless patient status monitor
Primary Device ID08809988780018
NIH Device Record Keyb8a8d95f-08f2-4d17-876e-64213e5eb6b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameXandar Kardian Monitoring Sensor XK300-H
Version Model NumberXK300-H
Company DUNS695005778
Company NameXandar Kardian Korea Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-833-695-2677
Emailsupport@xkcorp.com
Phone+1-833-695-2677
Emailsupport@xkcorp.com
Phone+1-833-695-2677
Emailsupport@xkcorp.com
Phone+1-833-695-2677
Emailsupport@xkcorp.com
Phone+1-833-695-2677
Emailsupport@xkcorp.com
Phone+1-833-695-2677
Emailsupport@xkcorp.com
Phone+1-833-695-2677
Emailsupport@xkcorp.com
Phone+1-833-695-2677
Emailsupport@xkcorp.com
Phone+1-833-695-2677
Emailsupport@xkcorp.com
Phone+1-833-695-2677
Emailsupport@xkcorp.com
Phone+1-833-695-2677
Emailsupport@xkcorp.com
Phone+1-833-695-2677
Emailsupport@xkcorp.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108809988780018 [Primary]

FDA Product Code

SBOBed-Patient Activity Monitoring System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-08
Device Publish Date2024-07-31

Devices Manufactured by Xandar Kardian Korea Inc.

08809988780018 - Xandar Kardian Monitoring Sensor XK300-H2024-08-08
08809988780018 - Xandar Kardian Monitoring Sensor XK300-H2024-08-08
08809988780001 - Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300)2024-01-29

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