ONE-CARE Pen Needles 3013

GUDID 00810008211632

The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a compatible insulin pen injector. It consists of a fine, thin-wall needle with an integrated safety cap and a universal screw-on or snap-on connection for compatibility with most insulin pen devices.

MediVena, LLC

Autoinjector needle

• Primary Device ID: 00810008211632
• NIH Device Record Key: b5db720b-7fd8-4d35-85d4-6327740d6682
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE-CARE Pen Needles
• Version Model Number: 3013-ONE-CARE Pen Needles 32G x 5mm, Brown, 100/bx
• Catalog Number: 3013
• 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
• 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: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 5 Millimeter
• Needle Gauge: 32 Gauge
• Length: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810008211618 [Primary]
GS1	00810008211632 [Package]; Contains: 00810008211618; Package: case [50 Units]; In Commercial Distribution

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: 2025-03-10
• Device Publish Date: 2025-02-28

On-Brand Devices [ONE-CARE Pen Needles]

• 00810008211632: The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
• 00810008215531: The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
• 00810008211175: The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin
• 00810008211656: he insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin