GoCheck MultiScreener

Basic Information

• Brand Name: GoCheck MultiScreener
• Primary DI: B43071000030
• Version / Model: i15 Pro
• Company Name: Gobiquity, Inc.
• Labeler DUNS: 035145840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-19
• Public Version: 2
• Public Version Date: 2026-02-16
• Public Version Status: Update
• Public Device Record Key: 677766a7-5b29-4550-bae7-03fa83ca9089

Device Description

GoCheck i15P MultiScreener Finished Device Assembly

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HKO	Refractometer, Ophthalmic	Ophthalmic	886.1760	1
MMF	Photorefractor	Ophthalmic	886.1120	2
HOX	Chart, Visual Acuity	Ophthalmic	886.1150	1
EWO	Audiometer	Ear, Nose, Throat	874.1050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16800	Vision testing/training chart	An ophthalmic chart or card printed with various symbols (e.g., letters, pictures or dots) intended to be used for testing visual acuity (e.g., Snellen chart) or testing and/or training accommodation and/or convergence or other amenable ophthalmic functions. The chart/card may be held in front of the patient or placed on a table or wall and may have specific user instructions depending on specific use. This is a reusable device.	No	Active
37503	Tone audiometer	An electroacoustic device intended for use in a clinical setting to generate tones in the audible range to measure the hearing threshold of a patient by establishing the level at which the patient first becomes aware of the sounds. The device controls tone intensity and frequency either by a computer or manually, and displays/records the patient's responses, typically in the form of an audiogram. It may include a bone vibrator for direct inner-ear stimulation.	No	Active
61569	External ocular measurement camera	A hand-held, battery-powered, optical device intended for digital image capture and analysis of the external ocular anatomy to assist in the diagnosis of ophthalmic abnormalities (e.g., ptosis, strabismus, glaucoma); it is not intended to capture images of the fundus. It consists of a digital camera which includes software intended to take specific ocular measurements (e.g., pupil diameter, horizontal visible iris diameter, margin reflex difference, interpupillary distance, strabismus angle).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B43071000030	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]