TRUEplus

Basic Information

• Brand Name: TRUEplus
• Primary DI: 00096295129113
• Version / Model: TRUEplus Pen Needles 31 GAUGE x 1/4"
• Catalog Number: S5002C31-100
• Company Name: TRIVIDIA HEALTH, INC.
• Labeler DUNS: 151810868
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 4
• Public Version Date: 2020-04-09
• Public Version Status: Update
• Public Device Record Key: d5e809b5-80f3-4292-9b35-087049f07d74
• Distribution End Date: 2020-03-11

Device Description

LEADER TRUEplus Pen Needles 31 GAUGE x 1/4"

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44127	Autoinjector needle	A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50096295129118	GS1	Case	30	Not in Commercial Distribution	2020-03-11
Primary	00096295129113	GS1
Unit of Use	00021292009007	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K143437	000

Device Sizes

Type	Value	Unit	Text
Length	0.25	Inch
Needle Gauge	31	Gauge