Blinq

Basic Information

• Brand Name: Blinq
• Primary DI: 00864816000421
• Version / Model: 1
• Company Name: REBISCAN, INC.
• Labeler DUNS: 831265967
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-31
• Public Version: 1
• Public Version Date: 2018-08-31
• Public Version Status: New
• Public Device Record Key: bddfb58c-76c1-4996-b0ad-a289d1c3e6ea

Device Description

Blinq Pediatric Vision Scanner

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• PM Exempt: No
• Has Serial Number: Yes
• 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
PMW	Strabismus Detection Device	Ophthalmic	886.1342	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63515	Paediatric strabismus screening scanner	An electrically-powered optic device designed for screening for strabismus and amblyopia risk in children (aged 2 to 8 years) by using retinal reflections of polarized laser light to/from both eyes simultaneously. It consists of a self-contained unit which includes a visually enticing interface for the child to look at, and provides a result, in the form of a recommendation for referral to an ophthalmologist, if an abnormality is detected.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00864816000421	GS1