Bynex

GUDID 06926515406400

Two-piece Ostomy open bag

Zhende Medical Co., Ltd.

Intestinal ostomy bag/support kit

• Primary Device ID: 06926515406400
• NIH Device Record Key: ea120834-351a-4370-bca0-3ba7601cd21c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bynex
• Version Model Number: NZ2151V1001-1
• Company DUNS: 654591569
• Company Name: Zhende Medical Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06926515406400 [Primary]

FDA Product Code

• PQE: Ostomy Care Kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-30
• Device Publish Date: 2023-06-22

On-Brand Devices [Bynex]

• 06926515406400: Two-piece Ostomy open bag
• 06926515406387: Two-piece ostomy bag Flat Wafer