Restored Rest

Basic Information

• Brand Name: Restored Rest
• Primary DI: 00860009595804
• Version / Model: Full Style S/M
• Catalog Number: 04
• Company Name: Restored Rest LLC
• Labeler DUNS: 005356594
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2023-01-12
• Public Version: 1
• Public Version Date: 2023-01-20
• Public Version Status: New
• Public Device Record Key: 67150edb-583e-43c3-8b11-9859ba167ecb

Device Description

CPAP mask cushion cover made of absorbent material. Helps make using a CPAP easier and more comfortable. Decreases slippage, leaks, and noise. Feels good on the skin. Keeps the cushion clean and extends the life of the cushion. Slips on the cushion easily and is held on by thin elastic. Patented design is slim and lightweight. As the cover goes on the cushion a space for the nose, or nose and mouth, opens automatically. Washable and reusable.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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: No
• 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
FRL	Fiber, Medical, Absorbent	General Hospital	880.5300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62720	Medical cushion cover	A device intended to cover a medical cushion (e.g., birthing cushion, lumbar cushion, wheelchair cushion) during use to protect the cushion from dirt/debris to maintain hygiene. It may be dedicated to a specific type of cushion or non-dedicated; it is not intended for surgical use and is not intended to cover a pillow primarily used in bed. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009595804	GS1
Unit of Use	00860009595835	GS1

Customer Contacts

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