VacSure EZ Care Pressure Activate Safety Lancet

GUDID 00850014448431

LABOTEK GROUP CORP

Blood lancet, single-use

• Primary Device ID: 00850014448431
• NIH Device Record Key: d0d31027-aafe-4e7a-9367-f0cc9ea30316
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VacSure EZ Care Pressure Activate Safety Lancet
• Version Model Number: VEZC-3015
• Company DUNS: 117338398
• Company Name: LABOTEK GROUP CORP
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850014448424 [Primary]
GS1	00850014448431 [Package]; Contains: 00850014448424; Package: Inner Pack [100 Units]; In Commercial Distribution
GS1	10850014448438 [Package]; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222376

FDA Product Code

• FMK: Single Use Only Blood Lancet With 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: 2024-12-11
• Device Publish Date: 2024-12-03

On-Brand Devices [VacSure EZ Care Pressure Activate Safety Lancet]

• 00850014448462: VEZC-2122
• 00850014448431: VEZC-3015