Parasol Wireless Patient Fall Prevention System

Basic Information

• Brand Name: Parasol Wireless Patient Fall Prevention System
• Primary DI: 00854636006642
• Version / Model: KEY01
• Company Name: Parasol Medical, LLC
• Labeler DUNS: 079786058
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: 9b0751dc-7b1f-4b75-b63d-fed931625adf

Device Description

Wireless Falls Monitor ID Key

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KMI	MONITOR, BED PATIENT	General Hospital	880.2400	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65797	Inpatient motion surveillance unit	An electrically-powered device designed to be used in a healthcare or assisted living setting to track the movements of an inpatient/resident for capture of high-risk behaviour (e.g., bedridden patient bed vacation attempt, fall risk) and to automatically send alert notifications to healthcare staff via a central monitoring station. It includes one or more cameras and a processing unit intended to detect, record, and transmit high-risk events based on predetermined motion threshold references.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854636006642	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Mono Plug Diameter: 0.125 Inch