FDA.reportPublic FDA data

ECKO

Primary DI
00840379058871
Brand
ECKO
Company
Q Eye Eyewear Corp
Model
ECKO READ01 1.5
Device description
Spectacles Readers
Published
2022-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HOISpectacle, magnifying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOISpectacle, MagnifyingOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840379058871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840379058871008403790588718403790588710840379058871

GMDN Terms#

Term, Definition table
TermDefinition
Magnifying spectaclesA device that consists of a spectacle frame with convex lenses intended to enlarge text/images for a visually impaired patient/person. It is made of plastic material or glass within a plastic or metal frame.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
826430894
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00193968439910MEMBERS MARKMMS200 BLK 542025-03-27
00193968439927MEMBERS MARKMMS201 BLK 542025-03-27
00193968439934MEMBERS MARKMMS202 BURG 512025-03-27
00193968439941MEMBERS MARKMMS203 BLK 612025-03-27
00193968439958MEMBERS MARKMMS204 BLK 602025-03-27
00193968441159MEMBERS MARKMMS100 GREEN 532025-03-27
00193968441166MEMBERS MARKMMS100 PINK 532025-03-27
00193968441173MEMBERS MARKMMS101 BURG 562025-03-27
00193968441180MEMBERS MARKMMS102 BLK 502025-03-27
00193968441197MEMBERS MARKMMS103 CRY 552025-03-27
00193968441203MEMBERS MARKMMS104 GREY 542025-03-27
00193968441210MEMBERS MARKMMS105 BLK 562025-03-27
00193968441227MEMBERS MARKMMS106 GUN 622025-03-27
00193968464202MEMBERS MARKMMS107 GOLD 532025-03-27
00193968472955MEMBERS MARKMMS206 CRY 552025-03-27
00193968472962MEMBERS MARKMMS205 BLK 532025-03-27
00840379061024MASTER PIECEMP6010 TORT 502025-03-27
00840379061031MASTER PIECEMP6010 PINK 502025-03-27
00840379061475MASTER PIECEMP6011 BLK 522025-03-27
00840379061482MASTER PIECEMP6011 GREY 522025-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770410873Bausch + LombBausch & Lomb IncorporatedHOI2025-08-18
00757770415496Bausch + LombBausch & Lomb IncorporatedHOI2025-08-18
00757770425211Bausch + LombBausch & Lomb IncorporatedHOI2025-08-18
00681131104302EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104333EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104340EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104357EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104364EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104371EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104388EquateWAL-MART STORES, INC.HOI2025-03-07
00802807320752NICOLE MILLEREvolutioneyes, Inc.HOI2024-07-03
00802807320776MAX STUDIOEvolutioneyes, Inc.HOI2024-07-03
00802807320769MAX STUDIOEvolutioneyes, Inc.HOI2024-07-03
00802807320745NICOLE MILLEREvolutioneyes, Inc.HOI2024-07-03
00802807320714NICOLE MILLEREvolutioneyes, Inc.HOI2024-06-26
00802807320653MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320660MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320677MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320738M BY MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320691MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320707MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320684MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807357499ESPECEvolutioneyes, Inc.HOI2024-06-26
00802807320486EVOLUTIONEYESEvolutioneyes, Inc.HOI2024-05-14
00802807320578MAX STUDIOEvolutioneyes, Inc.HOI2024-05-14
00802807320530M BY MAX STUDIOEvolutioneyes, Inc.HOI2024-05-14
00802807320493MAX EDITIONEvolutioneyes, Inc.HOI2024-05-14
00802807320554NICOLE MILLEREvolutioneyes, Inc.HOI2024-05-14
00802807320646NICOLE MILLEREvolutioneyes, Inc.HOI2024-05-14
00802807320592MAX STUDIOEvolutioneyes, Inc.HOI2024-05-14