SOL-GUARD™ Insulin Safety Syringe with Fixed Needle

Basic Information

• Brand Name: SOL-GUARD™ Insulin Safety Syringe with Fixed Needle
• Primary DI: 00818392013634
• Version / Model: 2331516SG
• Company Name: SOL-MILLENNIUM MEDICAL INC
• Labeler DUNS: 069590113
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• 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: 7ae5fb6d-9356-4eae-b0ba-27f2f19ba399

Device Description

The SOL-GUARD™ Safety Syringe is intended for the delivery of U-100 insulin. The SOL-GUARD™ Safety Sleeve covers the needle when activated. In the activated position, the Safety Shield guards against accidental needle stick.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: 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
17812	Needle guard	A cap/cover intended to be extended over a used needle (attached to a syringe/autoinjector or not) to prevent accidental needle sticks, typically during removal of the needle. It is typically a plastic housing with appropriate shielding to prevent injury upon application, and is typically disposed of with the needle; it is not the needle cap provided with the needle. This is a single-use device.	No	Active
38501	Insulin syringe/needle, basic	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10818392013631	GS1	Box	100	In Commercial Distribution
Primary	00818392013634	GS1
Package	20818392013638	GS1	Case	8	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	0.3	Milliliter
Length	8	Millimeter
Needle Gauge	31	Gauge