Regard™

Basic Information

• Brand Name: Regard™
• Primary DI: 00326053120282
• Version / Model: 382940REG
• Catalog Number: 382940REG
• Company Name: RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
• Labeler DUNS: 134472476
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-30
• Public Version: 1
• Public Version Date: 2023-07-10
• Public Version Status: New
• Public Device Record Key: 3f8b94f7-10f3-4117-92bb-3ba1ee05f6fd

Device Description

Pocket Slide-Lateral Transfer Tube-Disposable 36X40

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
FMR	Device, Transfer, Patient, Manual	General Hospital	880.6785	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37163	Patient transfer sliding mat	A manual device typically in the form of an open roll mat or flat sheet designed to be used by healthcare professionals to assist in the physical movement and transfer of a patient (e.g., hospitalized, disabled, geriatric) from one place to another. The device typically has no lifting capabilities and utilizes sliding techniques to move the patient. It is typically designed using low-friction artificial fibres and intended to be slid under the patient who is then gently pushed by attending staff to glide across the surface of the device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10326053120289	GS1		50	In Commercial Distribution
Primary	00326053120282	GS1