FDA.reportPublic FDA data

PU YUAN

Primary DI
06921825701450
Brand
PU YUAN
Company
Guangzhou Fuzelong Hygiene Material Co., Ltd.
Model
MC-0202L
Published
2025-07-10
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
16921825700856PackageGS150In Commercial Distribution
06921825701450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1692182570085616921825700856
06921825701450069218257014506921825701450

GMDN Terms#

Term, Definition table
TermDefinition
Eye splash shield, single-useA device intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It may have an open design like spectacles, or an enclosed design like goggles or a mask. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
546983737
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06921825703560PU YUANEar-loops2026-04-29
06921825703577PU YUANEar-loops2026-04-29
06921825703584PU YUANEar-loops2026-04-29
06921825703591PU YUANEar-loops2026-04-29
06921825703607PU YUANTie-on type2026-04-29
06921825703614PU YUANTie-on type2026-04-29
06921825703621PU YUANTie-on type2026-04-29
06921825703638PU YUANSurgical Gown2026-04-29
06921825703645PU YUANSurgical Gown2026-04-29
06921825703652PU YUANSurgical Gown2026-04-29
06921825703669PU YUANSurgical Gown2026-04-29
06921825703683PU YUANSurgical Gown2026-04-29
06921825703690PU YUANSurgical Gown2026-04-29
06921825703706PU YUANTie-on type2026-04-29
06921825701443PU YUANSB2F-HoodGown-XL-EL-M-FP2025-07-05
06921825701474PU YUANSB2F-HOOD-M2025-07-21
06921825701481PU YUANSB2F-HoodGown-XL-EL-M-FP2025-07-21
06921825700781PU YUANSB2F-PEELAWAY2024-12-06

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
00630094055114Bioseal Inc.BIOSEALHOY2024-01-29
00630094055138Bioseal Inc.BIOSEALHOY2024-01-29
00630094055145Bioseal Inc.BIOSEALHOY2024-01-29
00630094055190Bioseal Inc.BIOSEALHOY2024-01-29
00630094404721Bioseal Inc.BIOSEALHOY2024-01-29
00630094540160Bioseal Inc.BIOSEALHOY2024-01-29
00630094540337Bioseal Inc.BIOSEALHOY2024-01-29
00630094540474Bioseal Inc.BIOSEALHOY2024-01-29
00630094551913Bioseal Inc.BIOSEALHOY2024-01-29
00630094551937Bioseal Inc.BIOSEALHOY2024-01-29
00630094053707Bioseal Inc.BIOSEALHOY2024-01-26
00630094053738Bioseal Inc.BIOSEALHOY2024-01-26
00630094053905Bioseal Inc.BIOSEALHOY2024-01-26
00630094540016Bioseal Inc.BIOSEALHOY2024-01-26
08052276029638Eye Shield AKTIVE SRLHOY2024-01-15
00630094183411Bioseal Inc.BIOSEALHOY2023-10-05
00630094183459Bioseal Inc.BIOSEALHOY2023-10-05