Parasol Patient Fall Prevention System

Basic Information

• Brand Name: Parasol Patient Fall Prevention System
• Primary DI: 00854636006376
• Version / Model: PADS-01
• 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: 1dedd2b5-07c2-4983-9ead-2d98899201b4

Device Description

Wired Monitor with Wall Mount

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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	00854636006376	GS1