Parasol drySmart Real-Time Incontinence Monitoring Pad

Basic Information

• Brand Name: Parasol drySmart Real-Time Incontinence Monitoring Pad
• Primary DI: 00854636006468
• Version / Model: WDS-8090
• Company Name: Parasol Medical, LLC
• Labeler DUNS: 079786058
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• 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: 8d290658-7199-4080-988d-39c40ead5bba

Device Description

80x90 Incontinence Pad

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: Yes
• 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
60709	Draping incontinence liner	A non-sterile padded sheet intended to cover and protect a device/piece of furniture (e.g., wheelchair, bed, sofa) occupied by an incontinent person by catching and retaining urine. It is typically a multi-layered piece of fabric containing a mixture material types [e.g., synthetic (e.g., polypropylene fabric) and plant-derived materials (e.g., cellulose)] that is available in a variety of sizes. It is intended to be used in the home or healthcare facility. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	60854636006460	GS1
Primary	00854636006468	GS1

Device Sizes

Type	Value	Unit	Text
Length	90	Centimeter
Width	80	Centimeter