GoCheck Audiometric Headphone Assembly

GUDID B43061000060

Audiometric Headphone Final Assembly

Gobiquity, Inc.

Tone audiometer

• Primary Device ID: B43061000060
• NIH Device Record Key: 7e9ccaa8-d97c-4718-991f-4754b1bd2074
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GoCheck Audiometric Headphone Assembly
• Version Model Number: Sennheiser HD280 Pro
• 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	B43061000060 [Primary]

FDA Product Code

• ETT: Cushion, Earphone (For Audiometric Testing)

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

Devices Manufactured by Gobiquity, Inc.

• B43056000011000 - GoCheck: 2024-10-01 Mobile Application for Hearing Screening
• B43061000060 - GoCheck Audiometric Headphone Assembly: 2024-10-01Audiometric Headphone Final Assembly
• B43061000060 - GoCheck Audiometric Headphone Assembly: 2024-10-01 Audiometric Headphone Final Assembly
• B43071000020 - GoCheck MultiScreener: 2024-10-01 GoCheck i7P MultiScreener Finished Device Assembly
• B43050085440 - GoCheck Kids: 2024-08-05 GoCheck Kids (GCK) Vision Screener - Mobile Application works in conjunction with GCK Vision Screener Hardware (DI Number: B4307
• B43071000010 - GoCheck Kids: 2024-08-05 Photoscreener with Flash Concentrator, mobile platform (i.e., iPhone 15 Pro) and current GoCheck Kids software.
• B43060030010 - GoCheck Kids: 2023-07-14 Photoscreener with Flash Concentrator, mobile platform (i.e., iPhone 7 Plus) and current GoCheck Kids software.
• B430GCKIOS5430 - GoCheck Kids: 2023-06-23 GoCheck Kids mobile medical application for iPhone
• B430GCKNOK44290L - GoCheck Kids: 2018-03-29 Stand-alone software for GoCheck Kids Nokia.