Blinq

Primary DI
00864816000421
Brand
Blinq
Company
REBISCAN, INC.
Model
1
Device description
Blinq Pediatric Vision Scanner
Published
2018-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PMWStrabismus Detection Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMWStrabismus Detection DeviceOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864816000421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864816000421008648160004218648160004210864816000421

GMDN Terms#

Term, Definition table
TermDefinition
Paediatric strabismus screening scannerAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
831265967
Device count
1
DM exempt
true
Serial number
true