EMSRUN

Basic Information

• Brand Name: EMSRUN
• Primary DI: 06974567745268
• Version / Model: PZMZ0008
• Company Name: Wuxi Emsrun Technology Co., Ltd.
• Labeler DUNS: 542972552
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-02
• Public Version: 1
• Public Version Date: 2022-12-12
• Public Version Status: New
• Public Device Record Key: 36a70131-2010-40dc-8132-48bfa466568f

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38363	Face radiation shield	A transparent personal protective device intended to shield the face and eyes of a healthcare worker from unnecessary exposure to primary and scattered radiation associated with diagnostic medical and dental procedures. The shield is typically made from clear lead-equivalent materials, e.g., glass or plastic, and fits over the individual's face and normal spectacles, if these are being worn. It provides additional protection from radioactive liquids and body fluids. It may also be referred to as a visor or mask.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06974567745268	GS1