ONE-CARE Insulin Safety Syringes 2102

GUDID 00810008211564

ONE-CARE® Insulin Safety Syringes are single use devices intended for safe insulin delivery. They provide users with audible indication when the shield is pushed forward and then turned right or left to permanently lock the needle (''Click''). Large barrel flanges allow for secured grip and control of insulin dosing.

MediVena, LLC

Metered-delivery hypodermic syringe/needle

• Primary Device ID: 00810008211564
• NIH Device Record Key: 8b60d9b9-6d8d-44da-8190-09010bc142fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE-CARE Insulin Safety Syringes
• Version Model Number: ONE-CARE Insulin Safety Syringe, 0.5mL, 29G x 0.5
• Catalog Number: 2102
• 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: false

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

Device Dimensions

• Total Volume: 0.5 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 0.5 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 0.5 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 0.5 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 0.5 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 0.5 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 0.5 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 0.5 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 0.5 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 0.5 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 0.5 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 0.5 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 0.5 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 0.5 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 0.5 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 0.5 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 0.5 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 0.5 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810008211564 [Package]; Contains: 10810008210021; Package: case [10 Units]; In Commercial Distribution
GS1	10810008210021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150758

FDA Product Code

• MEG: Syringe, Antistick

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: 2023-10-24
• Device Publish Date: 2023-10-16

On-Brand Devices [ONE-CARE Insulin Safety Syringes]

• 00810008211564: ONE-CARE® Insulin Safety Syringes are single use devices intended for safe insulin delivery. Th
• 00810008211557: ONE-CARE Insulin Safety Syringes are sterile, single use devices intended for safe insulin deliv