ONE-CARE Luer-Lock Syringes

Basic Information

• Brand Name: ONE-CARE Luer-Lock Syringes
• Primary DI: 00810008216521
• Version / Model: ONE-CARE Luer-Lock Syringes 3ml
• Catalog Number: 2004
• Company Name: MediVena, LLC
• Labeler DUNS: 080740980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-18
• Public Version: 1
• Public Version Date: 2025-06-26
• Public Version Status: New
• Public Device Record Key: 64dca78e-01a4-4419-81db-8b18d5ac6a06

Device Description

The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration of fluids. It is composed of a transparent barrel with graduated markings for precise volume measurement, a plunger for controlled fluid delivery, and a Luer Lock connector that allows secure and leak-resistant attachment to compatible needles, catheters, or other devices with a Luer fitting. The syringe is available in various volumes (e.g., 1 mL, 3 mL, 5 mL, 10 mL, 20 mL). The device is intended for use in general medical, surgical, and laboratory applications.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMF	Syringe, Piston	General Hospital	880.5860	2
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41222	Medication transfer set	A collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00810008216538	GS1	box	100	In Commercial Distribution
Primary	00810008216521	GS1
Package	00810008218877	GS1	case	24	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	3	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 45 Degrees Celsius