GoCheck Kids

Basic Information

• Brand Name: GoCheck Kids
• Primary DI: B430GCKNOK44600
• Version / Model: Nokia 4.4.60
• Catalog Number: GCKNOK
• Company Name: GOBIQUITY, INC.
• Labeler DUNS: 035145840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-27
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: a2383d11-9f32-4760-a8ad-a12950b65e50

Device Description

GoCheck Kids stand-alone software version 4.4.60 for the Nokia device.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
MMF	Photorefractor	Ophthalmic	886.1120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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
Previous	B430GCKNOK44360	HIBCC
Primary	B430GCKNOK44600	HIBCC

Customer Contacts

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