Ezy Dose Self-Care

Basic Information

• Brand Name: Ezy Dose Self-Care
• Primary DI: 00031046605065
• Version / Model: 69797/69798
• Company Name: APOTHECARY PRODUCTS, LLC
• Labeler DUNS: 092312735
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-26
• Public Version: 1
• Public Version Date: 2021-04-05
• Public Version Status: New
• Public Device Record Key: 0d5a8725-da73-42a6-9e7b-d8bd62a0939f

Device Description

NATURAL EAR WAX REMOVAL SYSTEM

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
OGQ	Ear Irrigation Kit	General Hospital	880.6960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46259	Moisture/lubrication otic oil	An oil-based substance intended to be applied to the external auditory canal of the ear to provide moisture and/or lubrication typically to facilitate softening and/or removal of ear wax, removal of impurities, barrier to external water, and/or loosening of encrustations; it may in addition have antimicrobial and/or anti-inflammatory actions. It is typically applied as a liquid in a spray or as drops. It is normally available [non-prescription] over-the-counter (OTC). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20031046605069	GS1	INNER	3	In Commercial Distribution
Primary	00031046605065	GS1
Package	40031046605063	GS1	CASE	4	In Commercial Distribution
Package	10031046605062	GS1	CASE	48	In Commercial Distribution

Customer Contacts

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