Bynex

Basic Information

• Brand Name: Bynex
• Primary DI: 06948909401280
• Version / Model: 3005
• Company Name: Shaoxing Haoshide Medical Products Co., Ltd.
• Labeler DUNS: 420764429
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-01
• Public Version: 1
• Public Version Date: 2024-03-11
• Public Version Status: New
• Public Device Record Key: 68185476-3f0d-435c-9090-3ad7b5cf721a

Device Description

Ostomy Care Accessories 10 pieces/box 30 boxes/carton

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
EXE	Protector, Ostomy	Gastroenterology, Urology	876.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46207	Peristomal/periwound dressing	A non-sterile substance or material intended to be applied to peristomal and/or periwound skin intended to protect it from body effluent (e.g., faeces, urine, wound exudate) and/or to help secure the seal of a stomal appliance or wound dressing. The device is typically available in a variety of forms including cream, paste in a tube or other applicator, paste in ready formed strips, or powder. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06948909401280	GS1
Package	06948909453692	GS1	case	30	In Commercial Distribution