FDA.reportPublic FDA data

N/A

Primary DI
06979379450041
Brand
N/A
Company
Guangzhou Huiming Fibre Products Co., Ltd.
Model
E201
Device description
(Newborn) Phototherapy Protective Eye Mask Disposable Neonatal Phototherapy Eye Mask designed to protect infants' eyes from blue light exposure during phototherapy treatment.
Published
2026-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16979379450048PackageGS150In Commercial Distribution
26979379450045PackageGS11500In Commercial Distribution
06979379450041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697937945004816979379450048
2697937945004526979379450045
06979379450041069793794500416979379450041

GMDN Terms#

Term, Definition table
TermDefinition
Epiocular radiation shield, single-useAn opaque ocular covering intended to be used to shield the entire eye area of a patient or healthcare personnel from exposure to primary and scattered radiation (ionizing and/or non-ionizing) during a medical procedure [e.g., CT scan, dermatological laser treatment, phototherapy]. It is made of materials that prevent the transmission of harmful radiation to the eyes (e.g., lead, tungsten, plastic), and is typically in the form of a single or double opaque shield adhered to the face in front of the eyes (i.e. not directly on the corneal surface); it is not designed as goggles or spectacles. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
526896695
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16979379450093N/AB101+B1022026-05-07
06979379450010N/AE1022026-04-30
06979379450058N/AE3012026-04-29
06979379450027N/AE1032026-04-29
06979379450034N/AE1042026-04-29
06979379450065N/AE3022026-04-29
06979379450072N/AB1012026-04-29
06979379450089N/AB1022026-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770535583Bausch + LombBausch & Lomb IncorporatedHOY2026-04-30
16931918105420AllesetGRI Medical & Electronic Technology Co., Ltd.HOY2026-04-10
10620974004285BetterShieldSouthmedic IncorporatedHOY2025-12-19
D2481009320"""Heidi"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
D2481009330"""Ella"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
D2481009350"""Lucy"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
10827989003504Health Care Logistics, Inc®Health Care Logistics, Inc.HOY2025-01-08
TQ26126151971Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.HOY2024-12-09
10889483047910SunMed LLCSUNMED, LLCHOY2024-11-11
10887482176815BovieASPEN SURGICAL PRODUCTS, INC.HOY2024-08-26
00194613017101MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-08-15
00194613028190MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-08-15
00194613002770MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-04-25
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00630094055138Bioseal Inc.BIOSEALHOY2024-01-29
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