Red Tunica

Basic Information

• Brand Name: Red Tunica
• Primary DI: 00850036464488
• Version / Model: RT-37312
• Catalog Number: RT-37312
• Company Name: Rodimedi & Associates, Inc.
• Labeler DUNS: 785417726
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2024-01-08
• Public Version: 1
• Public Version Date: 2024-01-16
• Public Version Status: New
• Public Device Record Key: e1fb8a30-5350-4d0b-aa4b-2d2cc7276028

Device Description

Disposable Insulin Syringe With Needle For Single Use - 31G 0.5mL 8mm - 100 Pcs Box // 10 Bags of 10 Pcs

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
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
Package	10850036464485	GS1	Case	5	In Commercial Distribution
Primary	00850036464488	GS1
Unit of Use	00850036464471	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K151949	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	31	Gauge
Length	8	Millimeter
Total Volume	0.5	Milliliter