Bynex

Basic Information

• Brand Name: Bynex
• Primary DI: 06948909401372
• Version / Model: 2151V
• 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: 2023-08-03
• Public Version: 2
• Public Version Date: 2024-02-26
• Public Version Status: Update
• Public Device Record Key: e34e2c07-b217-48fe-a241-174fc0efdcad

Device Description

Two-piece ostomy open bag 10 pieces/box 20 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: 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
PQE	Ostomy Care Kit	Gastroenterology, Urology	876.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62525	Intestinal ostomy bag/support kit	A collection of devices intended to be used for attachment/replacement of an intestinal ostomy bag (for collecting intestinal output such as faeces following a colostomy or ileostomy procedure). It includes not only the intestinal ostomy bag and a base plate, but also additional ostomy fitting/maintenance supportive devices (e.g., towels, wipes, scissors). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06948909401372	GS1
Package	06948909453784	GS1	case	20	In Commercial Distribution