TRUEplus

Basic Information

• Brand Name: TRUEplus
• Primary DI: 00021292005818
• Version / Model: TRUEplus SINGLE-USE INSULIN syringes 29 gauge needle 0.5cc insulin
• Company Name: TRIVIDIA HEALTH, INC.
• Labeler DUNS: 151810868
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ca69f991-fdd9-4cfe-b60b-ddd77299387e

Device Description

TRUEplus SINGLE-USE INSULIN syringes 29 gauge needle 0.5cc insulin

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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
Primary	00021292005818	GS1
Unit of Use	00021292008000	GS1
Package	00096295125351	GS1	Box	10	In Commercial Distribution
Package	50096295125356	GS1	Case	8	In Commercial Distribution
Package	00087701426100	GS1	Box	10	In Commercial Distribution
Package	10087701426107	GS1	Case	8	In Commercial Distribution
Package	00021292007317	GS1	Box	10	Not in Commercial Distribution	2018-04-16
Package	10021292007314	GS1	Case	8	Not in Commercial Distribution	2018-04-16
Package	00021292004989	GS1	Box	10	In Commercial Distribution
Package	10021292004986	GS1	Case	8	In Commercial Distribution
Package	00041260385230	GS1	Box	10	In Commercial Distribution
Package	10041260385237	GS1	Case	8	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K993017	000

Device Sizes

Type	Value	Unit	Text
Length	0.50	Inch
Total Volume	0.5	Milliliter
Needle Gauge	29	Gauge