eBchek

GUDID 04712558769402

blood glucose monitoring system contains meter, test strips, lancing device and lancets

VISGENEER, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 04712558769402
• NIH Device Record Key: ff553ec6-3eb1-423b-b718-c78f3ac6ce09
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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	04712558769402 [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: 2023-07-13
• Device Publish Date: 2023-07-05

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