EarClear Rx 90001

GUDID 00856331006170

EarClear Rx Ear Wash Basin

NUANCE MEDICAL, LLC

Ear bowl

• Primary Device ID: 00856331006170
• NIH Device Record Key: 739587a3-8ff6-4e02-b716-73da9c15daf8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EarClear Rx
• Version Model Number: 90001
• Catalog Number: 90001
• Company DUNS: 078797666
• Company Name: NUANCE MEDICAL, LLC
• Device Count: 1
• DM Exempt: true
• 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: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(760)585-4849
• Email: george@cryodose.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856331006170 [Primary]

FDA Product Code

• FNY: BASIN, EMESIS

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: 2018-11-26
• Device Publish Date: 2018-10-25

On-Brand Devices [EarClear Rx]

• 00856331006231: EarClear Rx Ear Wash Kit Rigid
• 00856331006224: EarClear Rx Disposable Tips- 3 pack
• 00856331006217: EarClear Rx Disposable Tips- 20 pack
• 00856331006200: EarClear Rx Ear Wash System Rigid
• 00856331006194: EarClear Rx Ear Wash Kit Flexible
• 00856331006187: EarClear Rx Ear Wash System Flexible
• 00856331006170: EarClear Rx Ear Wash Basin