ONE-CARE TB Safety Syringes 2109

GUDID 00810008214176

ONE-CARE Tuberculin Safety Syringes with fixed needle are sterile, single use devices intended for injection of fluids into the body. Designed to aid in prevention of needle stick injuries. 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 dosing.

MediVena, LLC

Metered-delivery hypodermic syringe/needle

• Primary Device ID: 00810008214176
• NIH Device Record Key: 5cad4557-7c04-4c45-bb06-9eda5cede80f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE-CARE TB Safety Syringes
• Version Model Number: ONE-CARE TB Safety Syringes, 1mL, 25G x 5/8’’
• Catalog Number: 2109
• 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: 1 Milliliter
• Needle Gauge: 25 Gauge
• Length: 0.625 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 25 Gauge
• Length: 0.625 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 25 Gauge
• Length: 0.625 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 25 Gauge
• Length: 0.625 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 25 Gauge
• Length: 0.625 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 25 Gauge
• Length: 0.625 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 25 Gauge
• Length: 0.625 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 25 Gauge
• Length: 0.625 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 25 Gauge
• Length: 0.625 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 25 Gauge
• Length: 0.625 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 25 Gauge
• Length: 0.625 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 25 Gauge
• Length: 0.625 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 25 Gauge
• Length: 0.625 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 25 Gauge
• Length: 0.625 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 25 Gauge
• Length: 0.625 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 25 Gauge
• Length: 0.625 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 25 Gauge
• Length: 0.625 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 25 Gauge
• Length: 0.625 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810008214169 [Primary]
GS1	00810008214176 [Package]; Contains: 00810008214169; Package: case [10 Units]; In Commercial Distribution

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 TB Safety Syringes]

• 00810008214176: ONE-CARE Tuberculin Safety Syringes with fixed needle are sterile, single use devices intended f
• 00810008214145: ONE-CARE Tuberculin Safety Syringes with fixed needle are sterile, single use devices intended f
• 00810008214114: ONE-CARE Tuberculin Safety Syringes with fixed needle are sterile, single use devices intended f