Hualian

Basic Information

• Brand Name: Hualian
• Primary DI: 16941762600200
• Version / Model: HL507C
• Company Name: Changzhou Hualian Health Dressing Co., Ltd
• Labeler DUNS: 548795548
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2022-07-08
• Public Version: 1
• Public Version Date: 2022-07-18
• Public Version Status: New
• Public Device Record Key: e3be8156-c6f3-4126-85a3-c0716f32cd1d

Device Description

Medical Tape

Device Characteristics

• Single Use: Yes
• 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: No
• 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
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58986	Multi-purpose surgical skin adhesive tape	A long thin band of synthetic material coated on one side with a pressure-sensitive adhesive, intended to be used for a variety of surgical/clinical intervention external taping applications [e.g., draping a patient for surgery and /or creating a window around a site of intervention, creating a sterile barrier, fixing/sealing items to a patient (e.g., a stockinette), managing/organizing tubing, cables, and other operating room (OR) devices]. It is typically made of a plastic material or combination of materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26941762600214	GS1	CASE	360	In Commercial Distribution
Primary	16941762600200	GS1
Unit of Use	06941762600203	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	2.5	Centimeter
Length	9.14	Meter