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Xandar Kardian Monitoring Sensor XK300-H

by Xandar Kardian Korea Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 21 Oct 2026. What this means

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809988780018 UDI-DI Date31 Jul 2024ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Contactless patient status monitor
Model / Reference
XK300-H
Primary DI / UDI-DI
08809988780018
FDA Product Code
SBO
GMDN Term
Contactless patient status monitor
Device Class
Class I
Regulation Number
880.2400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Contactless patient status monitor

Other devices from Xandar Kardian Korea Inc.

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No