DMject Insulin Syringe

Primary DI
08800109007038
Brand
DMject Insulin Syringe
Company
Shinchang Medical Co., Ltd.
Model
"DMject Insulin Syringe 0.3mL 30G×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
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993017000PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGEShinchang Medical Co., Ltd.2000-02-25FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18800109007035PackageGS1100In Commercial Distribution
28800109007032PackageGS13000In Commercial Distribution
38800109007039PackageGS13000In Commercial Distribution
08800109007038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880010900703518800109007035
2880010900703228800109007032
3880010900703938800109007039
08800109007038088001090070388800109007038

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, basicA 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
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
469-250-1748rikfedie@gmail.com

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 DIBrandModelCatalogPublished
08800109007076DMject Insulin Syringe"DMject Insulin Syringe 0.5mL 30G×5/16"""2026-03-03
08800109007120DMject Insulin Syringe"DMject Insulin Syringe 1mL 31G×5/16"""2026-03-03
18800109007035DMject Insulin SyringeDMject Insulin Syringe 0.3mL 30G×5/16"2026-03-03
18800109007073DMject Insulin SyringeDMject Insulin Syringe 0.5mL 30G×5/16"2026-03-03
18800109007127DMject Insulin SyringeDMject Insulin Syringe 1mL 31G×5/16"2026-03-03
08800109000015Profi disposable syringe"Profi disposable syringe 1mL 23G×1"""2021-02-23
08800109000411Profi disposable syringe"Profi disposable syringe 3mL 23G×1"""2021-02-23
08800109000619Profi disposable syringe"Profi disposable syringe 5mL 23G×1"""2021-04-14
08800109001579Profi disposable syringe"Profi LDS syringe 1mL 23G×1"""2021-05-20
08800109001586Profi disposable syringe"Profi LDS syringe 1mL 25G×1"""2021-05-20
08800109001593Profi disposable syringe"Profi LDS syringe 1mL 26G×1"""2021-05-20
08800109050010Profi disposable syringe"Profi disposable syringe 1mL 23G×1"""2021-01-29
08800109050416Profi disposable syringe"Profi disposable syringe 3mL 23G×1"""2021-05-04
08800109050614Profi disposable syringe"Profi disposable syringe 5mL 23G×1"""2021-05-04
18800109001576Profi disposable syringeProfi LDS syringe 1mL 23G×1"2021-05-20
18800109001583Profi disposable syringeProfi LDS syringe 1mL 25G×1"2021-05-20
18800109001590Profi disposable syringeProfi LDS syringe 1mL 26G×1"2021-05-20
18800109050413Profi disposable syringeProfi disposable syringe 3mL 23G×1"2021-05-04
18800109050611Profi disposable syringeProfi disposable syringe 5mL 23G×1"2021-05-04
18800109000616Profi disposable syringeProfi disposable syringe 5mL 23G×1"2021-04-14

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Primary DI, Brand, Company table
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