DMject Insulin Syringe

Basic Information

• Brand Name: DMject Insulin Syringe
• Primary DI: 08800109007076
• Version / Model: DMject Insulin Syringe 0.5mL 30G×5/16"
• Company Name: Shinchang Medical Co., Ltd.
• Labeler DUNS: 631088403
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-03
• Public Version: 1
• Public Version Date: 2026-03-11
• Public Version Status: New
• Public Device Record Key: 6c20e214-a5cc-4cff-a4ce-10fbe8aff2c0

Device Description

1. Insulin Syringe 2. Intended use : For the injection of insulin and primarily in human. 3. Instructions for use 1) To expose plunger, remove large orange cap. 2) To expose needle, pull small orange cap STRAIGHT off, being careful not to bend needle. 3) To measure correct dosage align top edge of plunger tip with your dosage mark on the syringe scale. 4) Use syringe ONCE only. To prevent misuse after injection, destroy syringe and needle. 4. Warning For patients who mix two types of insulin, do not change (a) the order of mixing that the physician has prescribed or (b) the model and brand of the syringe without first consulting your physician or pharmacist. Failure to heed this warning can result in dosage error. 5. Storage Avoid direct sunlight and store at room temperature in a dry and clean place. 6. Caution Federal law restricts this device to sale by or on the order of a physician. 7. Expiry Date : 5 years from manufacturing date

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
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	18800109007073	GS1	Inner box	100	In Commercial Distribution
Primary	08800109007076	GS1
Package	28800109007070	GS1	Shipping Case	3000	In Commercial Distribution
Package	38800109007077	GS1	Shipping Case	3000	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K993017	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 30 Degrees Celsius