ONE-CARE TB Safety Syringes

Basic Information

• Brand Name: ONE-CARE TB Safety Syringes
• Primary DI: 00810008214107
• Version / Model: ONE-CARE TB Safety Syringes, 1mL, 28G x 0.5’’
• Catalog Number: 2107
• Company Name: MediVena, LLC
• Labeler DUNS: 080740980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-23
• Public Version: 1
• Public Version Date: 2023-10-31
• Public Version Status: New
• Public Device Record Key: f323f77b-4630-4f25-8d93-876cc556f684

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
MEG	Syringe, Antistick	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45042	Metered-delivery hypodermic syringe/needle	A sterile device consisting of a graduated barrel (cylinder) with plunger and an attached retractable-needle, intended to be used to deliver an accurate metered dose of a substance (e.g., medicine or drug) during a patient injection. The syringe is typically made of plastic/silicone with an anti-sticking plunger allowing for smooth plunger movement; after use, the plunger is fully retracted into the barrel providing protection against needle sticks, and rendering the device unusable. It may be referred to as a safety syringe and can be used by healthcare personnel or patients. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00810008214114	GS1	case	10	In Commercial Distribution
Primary	00810008214107	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K150758	000

Device Sizes

Type	Value	Unit	Text
Total Volume	1	Milliliter
Needle Gauge	28	Gauge
Length	0.5	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – 104 Degrees Fahrenheit