ONE-CARE 3301

GUDID 00810008211939

ONE-CARE OPTI Safety Pen Needles offer safety solution as the needle is automatically shielded and never exposed to prevent risk of accidental needle-sticks. Transparent shield allows clear visibility of the needle tip for easy priming. Needle Lock-Out is confirmed via disappearance of pink element after use to evidence that the needle has been permanently locked and can be safely disposed. Needle cannulas are of Ultra-Thin Wall technology, 30G diameter, tri-bevel, electropolished and lubricated. Universal design ensures tight fit and compatibility with different pens.

MediVena, LLC

Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle

• Primary Device ID: 00810008211939
• NIH Device Record Key: 2395b803-2143-42e6-bc3a-7483ad3d468d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE-CARE
• Version Model Number: ONE-CARE® OPTI Safety Pen Needles
• Catalog Number: 3301
• 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
• 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
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter
• Needle Gauge: 30 Gauge
• Length: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810008211922 [Primary]
GS1	00810008211939 [Package]; Contains: 00810008211922; Package: case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192677

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: 2023-10-04
• Device Publish Date: 2023-09-26

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