SOL-CARE™ Safety Syringe Allergy Tray

Basic Information

• Brand Name: SOL-CARE™ Safety Syringe Allergy Tray
• Primary DI: 10818392015345
• Version / Model: 100033IM
• Company Name: SOL-MILLENNIUM MEDICAL INC
• Labeler DUNS: 069590113
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 987f4f68-8343-4033-b2c2-66dbdfde676a

Device Description

A sterile, single use, safety syringe with a fixed needle that is used to inject fluids into, or withdraw fluids from, the body. In addition, the device is also designed to aid in the prevention of needle stick injuries

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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	20818392015342	GS1	Case	40	In Commercial Distribution
Primary	10818392015345	GS1
Unit of Use	00818392015348	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	0.5	Milliliter
Length	12.5	Millimeter
Needle Gauge	27	Gauge