PU YUAN

Basic Information

• Brand Name: PU YUAN
• Primary DI: 06921825701474
• Version / Model: SB2F-HOOD-M
• Company Name: Guangzhou Fuzelong Hygiene Material Co., Ltd.
• Labeler DUNS: 546983737
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-21
• Public Version: 1
• Public Version Date: 2025-07-29
• Public Version Status: New
• Public Device Record Key: 6b2531a7-1752-4f34-8853-0b10e3975290
• Distribution End Date: 2027-07-20

Device Description

Anti-splash diaphragm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	886.4750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58376	Eye splash shield, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06921825701474	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]