FDA.reportPublic FDA data

Eye Cups

Primary DI
00616784338002
Brand
Eye Cups
Company
Dynarex Corporation
Model
3380
Device description
Eye Cups in Sealed Vial
Published
2022-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXQCup, Eye

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXQCup, EyeUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151575000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151575000Dynarex Eye CupsDynarex Corporation2015-09-01LXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784338019PackageGS16In Commercial Distribution
00616784338033PackageGS150In Commercial Distribution
00616784338002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784338019006167843380196167843380190616784338019
00616784338033006167843380336167843380330616784338033
00616784338002006167843380026167843380020616784338002

GMDN Terms#

Term, Definition table
TermDefinition
Eye wash cupA receptacle designed to fit around the eye socket and which is filled with warm water or an eyewash solution and placed over the eye to allow the liquid to wash the affected eye. It is typically used as a first line measure when dust or other particles have inadvertently entered the eye. It is usually made of plastic, glass or a ceramic material and is intended for use in the home, in a clinical setting, or for hospitalized or institutionalized patients. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117346307Vital Signs Stand, Compatible with item 10843108562026-06-08
00840117349544Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm)8150BLK2026-06-08
00840117349568Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm)8161BLK2026-06-08
00840117327610Titan-700 Bariatric Rollator102172023-12-28
00840117325968Platform Attachment102122023-03-24
00840117326026Dynarex Bari + Max Bariatric Platform Attachment102132023-03-24
00616784020419Vivid-Flex, Adjustable Height Rollator102042019-10-07
00616784021515Compact Steerable Knee Walker, With Basket, Steel102152019-10-08
00616784021614Steerable Knee Walker with Basket102162019-10-08
00616784020815DynaGo Duo Transport Rollator With 7.5" Casters and Plastic Footrest102082019-11-13
00840117325913Bari + Max Bariatric HD Steel Walker, Weight Capacity 700 lb.101692023-01-09
00840117336483Steel Button Folding Walker with 5 Wheels, Adults101702024-06-17
00616784020013DynaGo Zoom - Aluminum Rollator with 3" Wheels102002019-10-07
00616784020112Vivid-Quad, Rollator, With 6" Caster , Blue10201BL2019-10-07
00616784020211Vivid-Terrain, Rollator with 7.5" Caster102022019-10-07
00616784020310Titan-500 Bariatric Rollator102032019-10-07
00616784020129Vivid-Quad, Rollator, With 6" Caster, Red10201RD2019-11-07
00616784020136Vivid-Quad, Rollator, With 6" Caster, Black10201BK2019-11-07
00616784020143Vivid-Quad, Rollator, With 6" Caster, Pink10201PK2019-11-07
00616784016016DMECare Solutions Two Button Folding Walker, Adult (32"-39")101602019-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00025715683546FlentsAPOTHECARY PRODUCTS, LLCLXQ2020-09-21
20025715683540FlentsAPOTHECARY PRODUCTS, LLCLXQ2020-09-21