DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756984614
• Version / Model: M2200-WHL2
• Catalog Number: M2200-WHL2
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-03
• Public Version: 3
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: e373dd43-a842-4821-a495-55bdcad03626

Device Description

CHAIR BELT, ALARM

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
13356	Wheelchair/chair/stander occupant restraint/support	A rigid or non-rigid device, typically a strap, belt, bar, harness or vest designed to be attached to a wheelchair/chair/stander and/or its occupant to stabilize the occupant’s position for prevention of slips and/or falls from the appliance and/or to provide postural support. Some types may also be used to secure a wheelchair occupant in a wheelchair while travelling in a motor vehicle. This device may also include the extensions needed to attach this device and may be available in various sizes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00749756984614	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]