Selfinject

Basic Information

• Brand Name: Selfinject
• Primary DI: 08586026571288
• Version / Model: U100 1ml 28G x 5/16”
• Catalog Number: AP03-24-00
• Company Name: CHIRANA T.Injecta, a. s.
• Labeler DUNS: 495329266
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-02
• Public Version: 2
• Public Version Date: 2025-11-18
• Public Version Status: Update
• Public Device Record Key: 36205c7a-c162-464b-a585-b583fda5ac63

Device Description

1ml U100 insulin syringe with integrated needle 28G x 5/16” (0,36 x 8mm) in blister packaging, for single use.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2
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	08586026571295	GS1	box	100	In Commercial Distribution
Primary	08586026571288	GS1
Package	48586026571293	GS1	carton	2000	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K242434	000

Device Sizes

Type	Value	Unit	Text
Total Volume	1	Milliliter
Needle Gauge	28	Gauge

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius