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
00840117308558Resp-O2 Aerosol Standard Adult Mask340002021-04-22
00840117308572Resp-O2 Aerosol Elongated Masks, Adult340032021-04-22
00840117308619Resp-O2 Small Volume Nebulizer 6 cc Cup341042021-04-22
00840117308633Resp-O2 Small Volume Nebulizer 6cc Cup341052021-04-22
00840117308657Resp-O2 Small Volume Nebulizer 6 cc Cup341202021-04-22
00840117311732Resp-O2 Aerosol Standard Mask, Pediatric340012021-04-22
00840117311770Resp-O2 Aerosol Elongated Masks, Pediatric340042021-04-22
00840117311794Resp-O2 Aerosol Face Tent Mask, Adult340052021-04-22
00840117311817Resp-O2 Small Volume Nebulizer341002021-04-22
00840117311831Resp-O2 Small Volume Nebulizer 6 cc Cup341012021-04-22
00840117311855Resp-O2 Small Volume Nebulizer 6 cc Cup341022021-04-22
00840117311879Resp-O2 Small Volume Nebulizer 6 cc Cup341032021-04-22
00840117311893Resp-O2 Small Volume Nebulizer 6 cc Cup341062021-04-22
00840117311916Resp-O2 Small Volume Pacifier Nebulizer Kit341072021-04-22
00840117318007Resp-O2 Tracheostomy Adult Mask340212021-04-22
00840117318014Resp-O2 Tracheostomy Pediatric Mask340222021-04-22
00840117318069Resp-O2 Tracheostomy Adult Mask340202021-04-22
00840117311756Resp-O2 Aerosol Standard Mask, Infant340022021-01-19
00840117311534Resp-O2 Oxygen Supply Tubing332002021-04-22
00840117311558Resp-O2 Oxygen Supply Tubing332012021-04-22

Other Devices Sharing Product Codes#

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