Sejoy

GUDID 16939663969908

include 10pcs/vial test strips

Sejoy Biomedical Co.,Ltd.

Glucose monitoring system IVD, home-use

• Primary Device ID: 16939663969908
• NIH Device Record Key: f9924291-b17c-429b-8284-eae412f0c0ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sejoy
• Version Model Number: BG-710b
• Company DUNS: 545241999
• Company Name: Sejoy Biomedical Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06939663969901 [Primary]
GS1	16939663969908 [Package]; Contains: 06939663969901; Package: [24 Units]; In Commercial Distribution

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

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: 2025-01-08
• Device Publish Date: 2024-12-31

Devices Manufactured by Sejoy Biomedical Co.,Ltd.

• 16939663969908 - Sejoy: 2025-01-08include 10pcs/vial test strips
• 16939663969908 - Sejoy: 2025-01-08 include 10pcs/vial test strips
• 26939663913656 - DORM DOC: 2024-05-22