Cleanse Right

GUDID 00860007911453

Cleanse Right- Ear Wax Removal Irrigation Kit

Blue Echo Care LLC

Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable 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