eBchek

GUDID 04712558769419

blood glucose test strips 50pcs

VISGENEER, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 04712558769419
• NIH Device Record Key: 5bc88adb-224b-4bbb-99ea-a1b35727f7c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eBchek
• Version Model Number: LS-03
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712558769419 [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