AccessGUDID - DEVICE: Xandar Kardian Monitoring Sensor XK300-H (08809988780018)

GUDID

Device Identifier (DI) Information

Brand Name: Xandar Kardian Monitoring Sensor XK300-H
Version or Model: XK300-H
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Xandar Kardian Korea Inc.

Primary DI Number: 08809988780018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 695005778 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
SBO	Bed-Patient Activity Monitoring System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b8a8d95f-08f2-4d17-876e-64213e5eb6b7
Public Version Date: August 08, 2024
Public Version Number: 1
DI Record Publish Date: July 31, 2024