AccessGUDID - DEVICE: Smart Caregiver (00812293016503)

GUDID

Device Identifier (DI) Information

Brand Name: Smart Caregiver
Version or Model: CC-433SO-SYS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Smart Caregiver Corporation

Primary DI Number: 00812293016503
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012082397 *Terms of Use

Device Description: Economy Monitor, 2 Outlets, 2 RB, 1 Floor Mat, 1 Bed Pad, 1 Motion Sensor, 2 AC Adapter

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?
35818	Bed/chair occupant movement pressure/vibration sensor	An electrically-powered electronic sensing pad (pressure- or mechanical vibration-sensing) designed to be placed under a bed and/or chair occupant to detect and/or measure occupant movement related to activities such as sleep, wakefulness, and/or bed/chair exit. Some types are able to detect in addition occupant respiration and heart rates; and some types function with an alarm/alert/notification system to indicate unattended occupant attempt to vacate bed/chair.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KMI	Monitor, Bed Patient

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: b24aa2c2-d04d-48d3-a172-6b4a7d40f51f
Public Version Date: September 13, 2023
Public Version Number: 2
DI Record Publish Date: May 23, 2022