ONE-CARE PRO Safety Lancets 1012

GUDID 00810008211021

MediVena ONE-CARE PRO Push Button Activated Safety Lancets are disposable, single-use, preloaded devices with needlestick prevention mechanism for blood micro-sampling. The product has T-shape main housing and concaved button for stable grip within the hand and easy activation. ONE-CARE PRO Safety Lancets feature long safety tab for convenient twist off and pull out, optimized skin contact area of round shape for convenient placement on the test site. Dual-spring mechanism allows for quick and reliable needle retraction to protect against accidental needlestick injuries. STEP 1 Twist off the safety cap by a full turn of 360 degree, then pull it out, STEP 2 Press the top push button to activate the device, STEP 3 Collect blood sample and dispose the safety lancet into sharps container.

MediVena, LLC

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• Primary Device ID: 00810008211021
• NIH Device Record Key: 3aa9fd77-85be-4640-9229-1e8f111f2d5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE-CARE PRO Safety Lancets
• Version Model Number: ONE-CARE PRO Safety Lancets, Button-Activated, 28G
• Catalog Number: 1012
• Company DUNS: 080740980
• Company Name: MediVena, LLC
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com
• Phone: 4045142586
• Email: info@medivena.com

Device Dimensions

• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter
• Needle Gauge: 28 Gauge
• Length: 1.5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810008210659 [Primary]
GS1	00810008211021 [Package]; Contains: 00810008210659; Package: case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222408

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: 2024-03-05
• Device Publish Date: 2024-02-26

On-Brand Devices [ONE-CARE PRO Safety Lancets]

• 00810008211021: MediVena ONE-CARE PRO Push Button Activated Safety Lancets are disposable, single-use, preloaded
• 00810008211014: MediVena ONE-CARE PRO Push Button Activated Safety Lancets are disposable, single-use, preloaded