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Basic Information

• Brand Name: none
• Primary DI: 06978521200008
• Version / Model: A-S
• Company Name: Ningbo Huirui Technology Co., Ltd.
• Labeler DUNS: 979750504
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-11
• Public Version: 1
• Public Version Date: 2025-04-21
• Public Version Status: New
• Public Device Record Key: 4aaccf8b-ac4a-41eb-ade4-b7c7527a01f4
• Distribution End Date: 2025-04-11

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
KIA	Cover, Cast	General Hospital	880.6185	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64560	Cast/bandage waterproof bathing cover, reusable	A device made of waterproof materials designed to be placed over a treated area of the body, typically a plaster cast, stitches, bandage, dressing, or PICC line, to keep the area dry while the user is having a shower or a bath. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06978521200008	GS1