Visgeneer https://gudid.fda.gov/gudid/app/admin/udi/recordDe

GUDID 04712558762342

25x2pcs

VISGENEER, INC.

Blood lancet, single-use

• Primary Device ID: 04712558762342
• NIH Device Record Key: 99476a11-d359-4b2f-8596-325fbfc26f0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visgeneer
• Version Model Number: 30G I
• Catalog Number: https://gudid.fda.gov/gudid/app/admin/udi/recordDe
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712558762342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222034

FDA Product Code

• QRK: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-24
• Device Publish Date: 2025-02-16

Devices Manufactured by VISGENEER, INC.

• 04712558762342 - Visgeneer: 2025-02-2425x2pcs
• 04712558762342 - Visgeneer: 2025-02-24 25x2pcs
• 04712558762694 - RightLance: 2025-02-24 reusable lancing device that is to be cleaned and disinfected between each use, to be used with the sterile single-use lancets
• 04712558761116 - eBuricacid: 2023-07-13 blood uric acid monitoring system contains meter 1pcs, test strip 25pcs, lancing device 1pcs and lancet 25pcs
• 04712558761123 - eBuricacid: 2023-07-13 blood uric acid test strip 25pcs
• 04712558761277 - LANCET: 2023-07-13 100pcs
• 04712558769037 - eB-series: 2023-07-13 blood uric acid control solution: one vial
• 04712558769402 - eBchek: 2023-07-13 blood glucose monitoring system contains meter, test strips, lancing device and lancets
• 04712558769419 - eBchek: 2023-07-13 blood glucose test strips 50pcs