Chongjen

Basic Information

• Brand Name: Chongjen
• Primary DI: 06974681690604
• Version / Model: CPE Gloves,S
• Company Name: SHANGHAI CHONGJEN INDUSTRY CO., LTD.
• Labeler DUNS: 560012294
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-19
• Public Version: 1
• Public Version Date: 2023-01-27
• Public Version Status: New
• Public Device Record Key: c12f5d6a-53a5-4f88-be09-9044c445f184

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: No
• Has Expiration Date: No
• 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
47000	Assistive glove/mitten	A garment specially designed/adapted to be worn on the hand(s) of a person with a disability to function as a protective barrier between the user's hand(s) and the external environment, typically to keep the hands warm and dry. It is typically constructed with features that facilitate easy donning, fastening, and removal (e.g., special shape to accommodate a disability, Velcro fasteners).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06974681690604	GS1