Blinq

GUDID 00864816000421

Blinq Pediatric Vision Scanner

REBISCAN, INC.

Paediatric strabismus screening scanner

• Primary Device ID: 00864816000421
• NIH Device Record Key: bddfb58c-76c1-4996-b0ad-a289d1c3e6ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blinq
• Version Model Number: 1
• Company DUNS: 831265967
• Company Name: REBISCAN, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• 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: false
• 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
GS1	00864816000421 [Primary]

FDA Product Code

• PMW: Strabismus Detection Device

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: 2018-08-31
• Device Publish Date: 2018-07-31