GoCheck

GUDID B43056000011000

Mobile Application for Hearing Screening

Gobiquity, Inc.

Tone audiometer

• Primary Device ID: B43056000011000
• NIH Device Record Key: efd5121e-4624-49ad-bd23-1aa719a338d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GoCheck
• Version Model Number: Hearing Mobile App V1.0.0
• Company DUNS: 035145840
• Company Name: Gobiquity, Inc.
• 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B43056000011000 [Primary]

FDA Product Code

• EWO: Audiometer

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: 2024-10-01
• Device Publish Date: 2024-09-23

On-Brand Devices [GoCheck]

• B43056000011000: Mobile Application for Hearing Screening
• B43056000011100: Mobile Application for Hearing Screening