DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756978408
• Version / Model: M70-600TS
• Catalog Number: M70-600TS
• 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: 2
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: e32c8b5c-c4f1-4b68-b74c-fbad94218568

Device Description

Turning and Positioning System

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
FMR	DEVICE, TRANSFER, PATIENT, MANUAL	General Hospital	880.6785	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37165	Patient transfer/turning sheet, single-use	A manual device in the form of a sturdy sheet intended to be used by healthcare professionals to assist in the physical movement and/or transfer of a recumbent patient from one position/location to another. The device may operate using sliding/rolling and/or lifting techniques to move the patient upon it. It is typically made of plastics or textiles and may incorporate handles. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50749756978403	GS1	Case	10	In Commercial Distribution
Primary	00749756978408	GS1

Customer Contacts

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