Cleanse Right

Basic Information

• Brand Name: Cleanse Right
• Primary DI: 00860007911446
• Version / Model: CR-EARSPRLKIT-1
• Company Name: Blue Echo Care LLC
• Labeler DUNS: 117048847
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-20
• Public Version: 1
• Public Version Date: 2024-06-28
• Public Version Status: New
• Public Device Record Key: a9d71ba0-8372-42f7-a7d9-b00fc8d42829

Device Description

Cleanse Right- Ear Wax Spiral, Drops and Bulb

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
62863	Ear canal irrigation kit, reusable	A collection of items intended to be used to flush cerumen (ear wax) out of the ear canal during an ear/nose/throat (ENT) procedure. It consists of a manually-operated flushing device (e.g., spray bottle, syringe) and accessory items (e.g., a cup to collect used irrigation solution). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860007911446	GS1