AccessGUDID - DEVICE: EyeCheq Kiosk (G699Q90630)

GUDID

Device Identifier (DI) Information

Brand Name: EyeCheq Kiosk
Version or Model: A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Q9063
Company Name: EYECHEQ INC.

Primary DI Number: G699Q90630
Issuing Agency: ICCBBA
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118608192 *Terms of Use

Device Description: Automated device stand designed to support, position, trigger, and retrieve results from ophthalmic diagnostic equipment during self-administered eye and health assessments in settings where clinical support is available if needed.

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):	Yes
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?
39659	Static ophthalmic equipment stand, electrically-adjusted	An electrically-powered device designed as a column or post, usually with a small flat surface top, used to provide support and position control for ophthalmic devices commonly used during an ophthalmic examination/treatment (e.g., a slit lamp, keratometer, refractometer). It typically has a powered height adjustment function enabling the clinician to align (raise/lower) the ophthalmic instruments to the eye level of the patient. It is typically stationary and may have drawers, shelves, and built-in outlets to supply low-voltage electricity to the instruments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMF	Stand, Instrument, Ac-Powered, Ophthalmic

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: fb0791d3-64fe-437e-a5e6-fd1ccf2be664
Public Version Date: October 25, 2024
Public Version Number: 1
DI Record Publish Date: October 17, 2024