GoCheck Kids

GUDID B43050085440

GoCheck Kids (GCK) Vision Screener - Mobile Application works in conjunction with GCK Vision Screener Hardware (DI Number: B43071000010) to make up GoCheck Kids Vision Screener Finished Device. Therefore, product codes and device listings are the same for Software Mobile Application and the Hardware for the GCK Vision Screener.

Gobiquity, Inc.

External ocular measurement camera

• Primary Device ID: B43050085440
• NIH Device Record Key: bd62599b-185e-4ada-888d-74bed862e285
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GoCheck Kids
• Version Model Number: Mobile Application Version 5.4.4
• 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: true
• Manufacturing Date: true
• 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	B43050085440 [Primary]

FDA Product Code

• MMF: Photorefractor

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: 2024-08-05
• Device Publish Date: 2024-07-26

On-Brand Devices [GoCheck Kids]

• B430GCKNOK44600: GoCheck Kids Native Software Application for Nokia.
• B430GCKNOK44360: GoCheck Kids stand-alone software version 4.4.60 for the Nokia device.
• B430GCKNOK44290L: Stand-alone software for GoCheck Kids Nokia.
• B430GCKIOS5430: GoCheck Kids mobile medical application for iPhone
• B43060030010: Photoscreener with Flash Concentrator, mobile platform (i.e., iPhone 7 Plus) and current GoCheck
• B43071000010: Photoscreener with Flash Concentrator, mobile platform (i.e., iPhone 15 Pro) and current GoCheck
• B43050085440: GoCheck Kids (GCK) Vision Screener - Mobile Application works in conjunction with GCK Vision Scr