ASSURE® ID Insulin 0.5cc Safety Syringe

Basic Information

• Brand Name: ASSURE® ID Insulin 0.5cc Safety Syringe
• Primary DI: 00015482102951
• Version / Model: 210295
• Company Name: ARKRAY USA, INC.
• Labeler DUNS: 008171162
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 4f76b69e-ea05-4b14-8069-3e8ef5c427de

Device Description

Sterile Safety Syringe

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: No
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMI	Needle, hypodermic, single lumen	General Hospital	880.5570	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	10015482102958	GS1	Carton	100	In Commercial Distribution
Primary	00015482102951	GS1
Package	20015482102955	GS1	Master Shipper	5	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K103011	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	29	Gauge
Total Volume	0.5	Milliliter
Length	0.5	Inch