Red Tunica

Basic Information

• Brand Name: Red Tunica
• Primary DI: 00850036464518
• Version / Model: RT-37435
• Catalog Number: RT-37435
• Company Name: Rodimedi & Associates, Inc.
• Labeler DUNS: 785417726
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• 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: bc9cf022-fcfc-470e-ad03-d6f2c1da0aab

Device Description

Safesulin™ Insulin Safety Syringe With Needle For Single Use - 29G 1.0mL 12.7mm - Individually Packed

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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
MEG	Syringe, Antistick	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34973	Insulin syringe/needle, safety	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; it includes an attached needle with a safety mechanism, such as cylinder/flap shielding or retraction into the barrel or sleeve after use, providing protection against needle sticks and rendering the device unusable. The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties (internally precoated with compatible substances) allowing smooth plunger movement. It 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	00850036464525	GS1	Inner Box	100	In Commercial Distribution
Primary	00850036464518	GS1
Package	10850036464522	GS1	Case	5	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K150758	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	29	Gauge
Length	12.7	Millimeter
Total Volume	1.0	Milliliter