Novidan

GUDID 00850049194242

NoviOne RIC OTC Hearing Aids, Pair - Charcoal

Novidan, Inc.

Air-conduction hearing aid, receiver-in-canal

• Primary Device ID: 00850049194242
• NIH Device Record Key: fc20b555-a3aa-4517-85e2-1d8c90d70e7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novidan
• Version Model Number: 99-0001-16
• Company DUNS: 117003805
• Company Name: Novidan, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850049194242 [Primary]

FDA Product Code

• QUF: Hearing Aid, Air-Conduction, Over The Counter

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: 2023-08-04
• Device Publish Date: 2023-07-27

On-Brand Devices [Novidan]

• 00850049194273: NoviOne BTE OTC Hearing Aids, Pair - Charcoal
• 00850049194266: NoviOne BTE OTC Hearing Aids, Pair - Slate
• 00850049194259: NoviOne BTE OTC Hearing Aids, Pair - Beige
• 00850049194242: NoviOne RIC OTC Hearing Aids, Pair - Charcoal
• 00850049194235: NoviOne RIC OTC Hearing Aids, Pair - Slate
• 00850049194228: NoviOne RIC OTC Hearing Aids, Pair - Beige
• 00850049194396: NoviOne RIC Rechargeable OTC Hearing Aids - Graphite Pair
• 00850049194389: NoviOne RIC Rechargeable OTC Hearing Aids - Beige Pair
• 00850049194372: NoviOne RIC Rechargeable OTC Hearing Aids - Glacier Pair
• 00850049194303: NoviOne RIC Wireless Rechargeable OTC Hearing Aids - Graphite Pair
• 00850049194297: NoviOne RIC Wireless Rechargeable OTC Hearing Aids - Beige Pair
• 00850049194280: NoviOne RIC W R, Wireless Rechargeable OTC Hearing Aid Pair, Glacier color
• 00850049194471: Novidan Mobile Application - Android
• 00850049194464: Novidan Mobile Application - iOS