Sonify Hearing

GUDID 00850049194082

Hearing Aid, Air-Conduction with Wireless Technology, OTC, Mach 1 Pro W OTC Hearing Aids - Slate, pair, 312 battery

Novidan, Inc.

Air-conduction hearing aid, receiver-in-canal

• Primary Device ID: 00850049194082
• NIH Device Record Key: 44654a1c-abeb-424e-80dd-190de2f1176a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonify Hearing
• Version Model Number: 99-0014-02
• 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

Customer Support Contacts

• Phone: 8336684326
• Email: info@sonifyhearing.com
• Phone: 8336684326
• Email: info@sonifyhearing.com
• Phone: 8336684326
• Email: info@sonifyhearing.com
• Phone: 8336684326
• Email: info@sonifyhearing.com
• Phone: 8336684326
• Email: info@sonifyhearing.com
• Phone: 8336684326
• Email: info@sonifyhearing.com
• Phone: 8336684326
• Email: info@sonifyhearing.com
• Phone: 8336684326
• Email: info@sonifyhearing.com
• Phone: 8336684326
• Email: info@sonifyhearing.com
• Phone: 8336684326
• Email: info@sonifyhearing.com
• Phone: 8336684326
• Email: info@sonifyhearing.com
• Phone: 8336684326
• Email: info@sonifyhearing.com
• Phone: 8336684326
• Email: info@sonifyhearing.com
• Phone: 8336684326
• Email: info@sonifyhearing.com
• Phone: 8336684326
• Email: info@sonifyhearing.com
• Phone: 8336684326
• Email: info@sonifyhearing.com
• Phone: 8336684326
• Email: info@sonifyhearing.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850049194082 [Primary]

FDA Product Code

• QUG: Hearing Aid, Air-Conduction With Wireless Technology, 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: 2023-07-04
• Device Publish Date: 2023-06-26

On-Brand Devices [Sonify Hearing]

• 00850049194099: Hearing Aid, Air-Conduction with Wireless Technology, OTC, Mach 1 Pro W OTC Hearing Aids - Charc
• 00850049194082: Hearing Aid, Air-Conduction with Wireless Technology, OTC, Mach 1 Pro W OTC Hearing Aids - Slate
• 00850049194075: Hearing Aid, Air-Conduction with Wireless Technology, OTC, Mach I Pro W OTC Hearing Aids - Beige
• 00850049194181: Mach I Pro OTC Hearing Aids - Charcoal
• 00850049194174: Mach I Pro OTC RIC Hearing Aids, Pair - Slate
• 00850049194167: Mach I Pro OTC RIC Hearing Aids, Pair - Beige
• 00850049194150: Mach I OTC BTE Hearing Aids, Pair - Charcoal
• 00850049194143: Mach I OTC BTE Hearing Aids, Pair - Slate
• 00850049194136: Mach I OTC BTE Hearing Aids, Pair - Beige
• 00850049194426: Mach II Pro OTC Hearing Aids - Graphite Pair
• 00850049194419: Mach II Pro OTC Hearing Aids - Beige Pair
• 00850049194402: Mach II Pro OTC Hearing Aids - Glacier Pair
• 00850049194334: Mach II Pro Wireless OTC Hearing Aids - Graphite Pair
• 00850049194327: Mach II Pro Wireless OTC Hearing Aids - Beige Pair
• 00850049194310: Mach II Pro Wireless OTC Hearing Aids - Glacier Pair