Cleanse Right

GUDID 00860007911453

Cleanse Right- Ear Wax Removal Irrigation Kit

Blue Echo Care LLC

Ear canal irrigation kit, reusable

• Primary Device ID: 00860007911453
• NIH Device Record Key: 9d1eee68-2015-4ee4-a668-ba97fc0b240d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cleanse Right
• Version Model Number: CR-EARKIT-1
• Company DUNS: 117048847
• Company Name: Blue Echo Care LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007911453 [Primary]

FDA Product Code

• OGQ: Ear Irrigation Kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-28
• Device Publish Date: 2024-06-20

On-Brand Devices [Cleanse Right]

• 00860007911460: Cleanse Right - Professional Electronic Ear Wax Remover
• 00860007911453: Cleanse Right- Ear Wax Removal Irrigation Kit
• 00860007911446: Cleanse Right- Ear Wax Spiral, Drops and Bulb