Easy Breathe

Basic Information

• Brand Name: Easy Breathe
• Primary DI: 00850000495234
• Version / Model: 850000495234
• Company Name: Aso LLC
• Labeler DUNS: 152793493
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2020-04-29
• Public Version: 2
• Public Version Date: 2023-09-22
• Public Version Status: Update
• Public Device Record Key: e81edc63-0ee1-4042-91ab-9a3ba6426f10
• Distribution End Date: 2020-05-02

Device Description

Sleep Strips, tan 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	20850000495238	GS1	Case	36	Not in Commercial Distribution	2020-05-02
Primary	00850000495234	GS1
Unit of Use	60850000495236	GS1

Customer Contacts

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