AccessGUDID - DEVICE: Restored Rest (00860009595804)

GUDID

Device Identifier (DI) Information

Brand Name: Restored Rest
Version or Model: Full Style S/M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 04
Company Name: Restored Rest LLC

Primary DI Number: 00860009595804
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 005356594 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRL	Fiber, Medical, Absorbent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 67150edb-583e-43c3-8b11-9859ba167ecb
Public Version Date: January 20, 2023
Public Version Number: 1
DI Record Publish Date: January 12, 2023