1st Tier Unilet

GUDID 00761059565000

1st Tier Unilet lancets 28G

OWEN MUMFORD USA INCORPORATED

Blood lancing device tip

• Primary Device ID: 00761059565000
• NIH Device Record Key: 49a2d2a2-d5f9-4ce3-af79-811bb30b7aaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1st Tier Unilet
• Version Model Number: AT 0565FT
• Company DUNS: 803401454
• Company Name: OWEN MUMFORD USA INCORPORATED
• Device Count: 100
• 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: true
• OTC Over-The-Counter: true

Device Dimensions

• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00761059565000 [Unit of Use]
GS1	00761059565369 [Primary]

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: 2023-04-07
• Device Publish Date: 2023-03-30

On-Brand Devices [1st Tier Unilet]

• 00761059585008: 1st Tier Unilet Lancets 33G
• 00761059575009: 1st Tier Unilet Lancets 30G
• 00761059565000: 1st Tier Unilet lancets 28G