Go Hearing

GUDID 00850022464454

These hearing aids are for users age 18 and older to compensate for perceived mild-to-moderate hearing impairment.

HEARX GROUP (PTY) LTD

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 00850022464454
• NIH Device Record Key: 68b29b3b-2ab8-43e0-b912-64ef79f0be46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Go Hearing
• Version Model Number: Go Prime (C600)
• Company DUNS: 539177681
• Company Name: HEARX GROUP (PTY) LTD
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1 302 754 3190
• Email: support@gohearing.com
• Phone: +1 302 754 3190
• Email: support@gohearing.com
• Phone: +1 302 754 3190
• Email: support@gohearing.com
• Phone: +1 302 754 3190
• Email: support@gohearing.com
• Phone: +1 302 754 3190
• Email: support@gohearing.com
• Phone: +1 302 754 3190
• Email: support@gohearing.com
• Phone: +1 302 754 3190
• Email: support@gohearing.com
• Phone: +1 302 754 3190
• Email: support@gohearing.com
• Phone: +1 302 754 3190
• Email: support@gohearing.com
• Phone: +1 302 754 3190
• Email: support@gohearing.com
• Phone: +1 302 754 3190
• Email: support@gohearing.com
• Phone: +1 302 754 3190
• Email: support@gohearing.com
• Phone: +1 302 754 3190
• Email: support@gohearing.com
• Phone: +1 302 754 3190
• Email: support@gohearing.com
• Phone: +1 302 754 3190
• Email: support@gohearing.com
• Phone: +1 302 754 3190
• Email: support@gohearing.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Please keep device dry at all times
• Special Storage Condition, Specify: Between 0 and 0 *Please keep device dry at all times
• Special Storage Condition, Specify: Between 0 and 0 *Please keep device dry at all times
• Special Storage Condition, Specify: Between 0 and 0 *Please keep device dry at all times
• Special Storage Condition, Specify: Between 0 and 0 *Please keep device dry at all times
• Special Storage Condition, Specify: Between 0 and 0 *Please keep device dry at all times
• Special Storage Condition, Specify: Between 0 and 0 *Please keep device dry at all times
• Special Storage Condition, Specify: Between 0 and 0 *Please keep device dry at all times
• Special Storage Condition, Specify: Between 0 and 0 *Please keep device dry at all times
• Special Storage Condition, Specify: Between 0 and 0 *Please keep device dry at all times
• Special Storage Condition, Specify: Between 0 and 0 *Please keep device dry at all times
• Special Storage Condition, Specify: Between 0 and 0 *Please keep device dry at all times
• Special Storage Condition, Specify: Between 0 and 0 *Please keep device dry at all times
• Special Storage Condition, Specify: Between 0 and 0 *Please keep device dry at all times
• Special Storage Condition, Specify: Between 0 and 0 *Please keep device dry at all times
• Special Storage Condition, Specify: Between 0 and 0 *Please keep device dry at all times

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850022464454 [Primary]

FDA Product Code

• ESD: Hearing Aid, Air Conduction

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: 2022-04-21
• Device Publish Date: 2022-04-13

On-Brand Devices [Go Hearing]

• 00850022464461: These hearing aids are for users age 18 and older to compensate for perceived mild-to-moderate h
• 00850022464454: These hearing aids are for users age 18 and older to compensate for perceived mild-to-moderate h
• 00850022464959: Go Hearing, Go Ultra BTE OTC hearing aid, Grey.
• 10810153660054: Go Hearing - Go Ultra - Gray - BTE - WAG Online - CASE
• 00810153660057: Go Hearing - Go Ultra - Gray - BTE - WAG Online