Home GUDID 08800109007120 DMject Insulin Syringe
Primary DI 08800109007120
Brand DMject Insulin Syringe
Company Shinchang Medical Co., Ltd.
Model "DMject Insulin Syringe 1mL 31G×5/16"""
Device description 1. Insulin Syringe2. Intended use : For the injection of insulin and primarily in human.3. Instructions for use1) 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. WarningFor 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. StorageAvoid direct sunlight and store at room temperature in a dry and clean place.6. CautionFederal law restricts this device to sale by or on the order of a physician.7. Expiry Date : 5 years from manufacturing date
Published 2026-03-03
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true
Product Codes# Code, Name table Code Name FMF Syringe, Piston
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FMF Syringe, Piston General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 18800109007127 Package GS1 100 In Commercial Distribution 28800109007124 Package GS1 3000 In Commercial Distribution 38800109007121 Package GS1 3000 In Commercial Distribution 08800109007120 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 18800109007127 18800109007127 28800109007124 28800109007124 38800109007121 38800109007121 08800109007120 08800109007120 8800109007120
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 631088403 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08800109007038 DMject Insulin Syringe "DMject Insulin Syringe 0.3mL 30G×5/16""" 2026-03-03 08800109007076 DMject Insulin Syringe "DMject Insulin Syringe 0.5mL 30G×5/16""" 2026-03-03 18800109007035 DMject Insulin Syringe DMject Insulin Syringe 0.3mL 30G×5/16" 2026-03-03 18800109007073 DMject Insulin Syringe DMject Insulin Syringe 0.5mL 30G×5/16" 2026-03-03 18800109007127 DMject Insulin Syringe DMject Insulin Syringe 1mL 31G×5/16" 2026-03-03 08800109000015 Profi disposable syringe "Profi disposable syringe 1mL 23G×1""" 2021-02-23 08800109000411 Profi disposable syringe "Profi disposable syringe 3mL 23G×1""" 2021-02-23 08800109000619 Profi disposable syringe "Profi disposable syringe 5mL 23G×1""" 2021-04-14 08800109001579 Profi disposable syringe "Profi LDS syringe 1mL 23G×1""" 2021-05-20 08800109001586 Profi disposable syringe "Profi LDS syringe 1mL 25G×1""" 2021-05-20 08800109001593 Profi disposable syringe "Profi LDS syringe 1mL 26G×1""" 2021-05-20 08800109050010 Profi disposable syringe "Profi disposable syringe 1mL 23G×1""" 2021-01-29 08800109050416 Profi disposable syringe "Profi disposable syringe 3mL 23G×1""" 2021-05-04 08800109050614 Profi disposable syringe "Profi disposable syringe 5mL 23G×1""" 2021-05-04 18800109001576 Profi disposable syringe Profi LDS syringe 1mL 23G×1" 2021-05-20 18800109001583 Profi disposable syringe Profi LDS syringe 1mL 25G×1" 2021-05-20 18800109001590 Profi disposable syringe Profi LDS syringe 1mL 26G×1" 2021-05-20 18800109050413 Profi disposable syringe Profi disposable syringe 3mL 23G×1" 2021-05-04 18800109050611 Profi disposable syringe Profi disposable syringe 5mL 23G×1" 2021-05-04 18800109000616 Profi disposable syringe Profi disposable syringe 5mL 23G×1" 2021-04-14
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