eBchek

GUDID 14712558769409

VISGENEER, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 14712558769409
• NIH Device Record Key: 2f0ca023-0a85-4e92-a6a9-eecb273f317f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eBchek
• Version Model Number: eB-S01
• Company DUNS: 656031619
• Company Name: VISGENEER, INC.
• 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: true
• Lot Batch: true
• Serial Number: true
• 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	14712558769409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122181

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: 2021-04-02
• Device Publish Date: 2021-03-25

On-Brand Devices [eBchek]

• 14712558769416: eB-S01
• 14712558769409: eB-S01
• 04712558769419: blood glucose test strips 50pcs
• 04712558769402: blood glucose monitoring system contains meter, test strips, lancing device and lancets