AccessGUDID - DEVICE: Parasol Patient Fall Prevention System (00854636006345)

GUDID

Device Identifier (DI) Information

Brand Name: Parasol Patient Fall Prevention System
Version or Model: SB6L890
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Parasol Medical, LLC

Primary DI Number: 00854636006345
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 079786058 *Terms of Use

Device Description: 90 Day Bed Pad with 8 Foot Cord

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":	Yes
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
Device Size Text, specify: Cord Length: 8 Feet
Length: 29 Inch
Width: 10 Inch

Device Record Status

Public Device Record Key: 2b5c663d-934d-4a37-b8bc-445a860b57b8
Public Version Date: September 13, 2023
Public Version Number: 2
DI Record Publish Date: December 07, 2022