Beyond Sleep

Basic Information

• Brand Name: Beyond Sleep
• Primary DI: 00667560060471
• Version / Model: 667560060471
• Company Name: KOBAYASHI CONSUMER PRODUCTS, LLC
• Labeler DUNS: 618672760
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 21
• Record Status: Published
• Publish Date: 2020-07-01
• Public Version: 2
• Public Version Date: 2022-12-23
• Public Version Status: Update
• Public Device Record Key: 2d2c3c84-c4de-464f-94ef-e34b9e5e65c0

Device Description

Anti-Snoring Strips

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: 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: Yes
• 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
LWF	DILATOR, NASAL	Ear, Nose, Throat	874.3900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47606	Nasal breathing aid, external	An external device intended to improve breathing by decreasing nasal resistance, thus increasing nasal airflow. The device typically consists of an adhesive bandage with two parallel elastic strips placed on the bridge of the nose; it acts with an upward pulling force to flare the nostrils and open the nares. It provides temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or nasal congestion. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10667560060478	GS1	box	36	In Commercial Distribution
Primary	00667560060471	GS1
Unit of Use	60667560060473	GS1
Package	10667560060591	GS1	box	12	In Commercial Distribution

Customer Contacts

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