AccessGUDID - DEVICE: PU YUAN (06921825701474)

GUDID

Device Identifier (DI) Information

Brand Name: PU YUAN
Version or Model: SB2F-HOOD-M
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Guangzhou Fuzelong Hygiene Material Co., Ltd.

Primary DI Number: 06921825701474
Issuing Agency: GS1
Commercial Distribution End Date: July 20, 2027
Device Count: 1
Labeler D-U-N-S® Number*: 546983737 *Terms of Use

Device Description: Anti-splash diaphragm

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6b2531a7-1752-4f34-8853-0b10e3975290
Public Version Date: July 29, 2025
Public Version Number: 1
DI Record Publish Date: July 21, 2025