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
00616784351612Heavy Duty Fitted Cot Sheet, White, 30" x 73"35162021-09-01
00616784351711Premium Flat Cot Sheet, Dark Blue, 40" x 85"35172021-09-01
00616784368115Triangular Bandages, Non-Woven, Polybagged, 40" x 40" x 56"36812021-09-01
00616784369228Cotton Stockinette, Soft Stretch Bandage, 2" x 25 yd36922021-09-01
00616784369327Cotton Stockinette, Soft Stretch Bandage, 3" x 25 yd36932021-09-01
00616784369426Cotton Stockinette, Soft Stretch Bandage, 4" x 25 yd36942021-09-01
00616784369624Cotton Stockinette36962021-09-01
00840117349841IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm)70552026-06-30
00616784201221Lab Jackets Knitted Cuffs & Collar with Pockets, Small, Blue20122021-09-01
00616784201320Lab Jackets Knitted Cuffs & Collar with Pockets, Medium, Blue20132021-09-01
00616784201429Lab Coats Knitted Cuffs & Collar with Pockets, Large, Blue20142021-09-01
00616784201528Lab Jackets Knitted Cuffs & Collar with Pockets, X-Large, Blue20152021-09-01
00616784201627Lab Jackets Knitted Cuffs & Collar with Pockets, 2X-Large, Blue20162021-09-01
00616784206226Lab Coats Knitted Cuffs & Collar with Pockets, Small, White20622021-09-01
00616784206325Lab Coats Knitted Cuffs & Collar with Pockets, Medium, White20632021-09-01
00616784206424Lab Coats Knitted Cuffs & Collar with Pockets, Large, White20642021-09-01
00616784206523Lab Coats Knitted Cuffs & Collar with Pockets, X-Large, White20652021-09-01
00616784206622Lab Coats Knitted Cuffs & Collar with Pockets, 2X-Large, White20662021-09-01
00616784207223Lab Coats Knitted Cuffs & Collar with Pockets, Small, Blue20722021-09-01
00616784207322Lab Coats Knitted Cuffs & Collar with Pockets, Medium, Blue20732021-09-01

Other Devices Sharing Product Codes#

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