GoCheck Kids

GUDID B43071000010

Photoscreener with Flash Concentrator, mobile platform (i.e., iPhone 15 Pro) and current GoCheck Kids software.

Gobiquity, Inc.

External ocular measurement camera

• Primary Device ID: B43071000010
• NIH Device Record Key: 618e81b3-824b-45ae-97fe-3e0371d931ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GoCheck Kids
• Version Model Number: V5 i15 PFC
• 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	B43071000010 [Primary]

FDA Product Code

• HKO: Refractometer, Ophthalmic

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