TRUEplus

Basic Information

• Brand Name: TRUEplus
• Primary DI: 00021292005832
• Version / Model: TRUEplus SINGLE-USE INSULIN syringes 30 gauge needle 0.3cc 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: 53c6acfb-993a-4f85-b8e5-047c7b735234

Device Description

TRUEplus SINGLE-USE INSULIN syringes 30 gauge needle 0.3cc 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	00021292005832	GS1
Unit of Use	00021292007973	GS1
Package	00087701426124	GS1	Box	10	In Commercial Distribution
Package	10087701426121	GS1	Case	8	In Commercial Distribution
Package	00021292005009	GS1	Box	10	In Commercial Distribution
Package	10021292005006	GS1	Case	8	In Commercial Distribution
Package	00096295125375	GS1	Box	10	In Commercial Distribution
Package	50096295125370	GS1	Case	8	In Commercial Distribution
Package	00052569138168	GS1	Box	10	In Commercial Distribution
Package	10052569138165	GS1	Case	8	In Commercial Distribution
Package	00010939699442	GS1	Box	10	In Commercial Distribution
Package	10010939699449	GS1	Case	8	In Commercial Distribution
Package	00021292007331	GS1	Box	10	Not in Commercial Distribution	2018-04-16
Package	10021292007338	GS1	Case	8	Not in Commercial Distribution	2018-04-16
Package	00041260385070	GS1	Box	10	In Commercial Distribution
Package	10041260385077	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	0.31	Inch
Total Volume	0.3	Milliliter
Needle Gauge	30	Gauge