DMject Insulin Syringe

GUDID 18800109007073

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

Shinchang Medical Co., Ltd.

Insulin syringe/needle, basic

• Primary Device ID: 18800109007073
• NIH Device Record Key: 6c20e214-a5cc-4cff-a4ce-10fbe8aff2c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DMject Insulin Syringe
• Version Model Number: DMject Insulin Syringe 0.5mL 30G×5/16"
• Company DUNS: 631088403
• Company Name: Shinchang Medical Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800109007076 [Primary]
GS1	18800109007073 [Package]; Contains: 08800109007076; Package: Inner box [100 Units]; In Commercial Distribution
GS1	28800109007070 [Package]; Package: Shipping Case [3000 Units]; In Commercial Distribution
GS1	38800109007077 [Package]; Contains: 08800109007076; Package: Shipping Case [3000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993017

FDA Product Code

• FMF: Syringe, Piston

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-11
• Device Publish Date: 2026-03-03

On-Brand Devices [DMject Insulin Syringe]

• 18800109007127: 1. Insulin Syringe 2. Intended use : For the injection of insulin and primarily in human. 3. Ins
• 18800109007073: 1. Insulin Syringe 2. Intended use : For the injection of insulin and primarily in human. 3. Ins
• 18800109007035: 1. Insulin Syringe 2. Intended use : For the injection of insulin and primarily in human. 3. Ins