AccessGUDID - DEVICE: GoCheck Kids (B430GCKNOK44600)

GUDID

Device Identifier (DI) Information

Brand Name: GoCheck Kids
Version or Model: Nokia 4.4.60
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GCKNOK
Company Name: Gobiquity, Inc.

Primary DI Number: B430GCKNOK44600
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 035145840 *Terms of Use
Previous DI: B430GCKNOK44360

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMF	Photorefractor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a2383d11-9f32-4760-a8ad-a12950b65e50
Public Version Date: July 17, 2024
Public Version Number: 3
DI Record Publish Date: February 27, 2017