ONE-CARE 3350

GUDID 00810008212080

ONE-CARE DUO Safety Pen Needles are intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the two safety shields on the patient-end and the pen connection-end automatically cover and lock the needle to minimize the risk of accidental needle sticks.

MediVena, LLC

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• Primary Device ID: 00810008212080
• NIH Device Record Key: 889c027c-0c8c-414d-b376-43e381515676
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE-CARE
• Version Model Number: ONE-CARE DUO Safety Pen Needles
• Catalog Number: 3350
• 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: true
• 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

Device Dimensions

• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810008212080 [Primary]
GS1	00810008214299 [Package]; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210864

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

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: 2023-10-06
• Device Publish Date: 2023-09-28

On-Brand Devices [ONE-CARE]

• 00810008210994: ONE-CARE Control Solution (Level 1 – Low and Level 3 - High) contains a known amount of glucos
• 00810008210512: ONE-CARE test strips are intended for use with ONE-CARE glucose meters for the quantitative meas
• 00810008210451: ONE-CARE glucose monitoring system is intended for the quantitative measurement of glucose in fr
• 00810008210499: ONE-CARE PRO test strips are intended for use with ONE-CARE PRO glucose meters for the quantitat
• 00810008210031: ONE-CARE PRO glucose monitoring system is intended for the quantitative measurement of glucose i
• 00810008212103: ONE-CARE OPTI Safety Pen Needles 30G x 8mm offer safety solution as the needle is automatically
• 00810008211939: ONE-CARE OPTI Safety Pen Needles offer safety solution as the needle is automatically shielded a
• 00810008212080: ONE-CARE DUO Safety Pen Needles are intended for use with a pen injector device for the subcutan