DMject Insulin Syringe

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…

Registry build 21.09.26

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

60manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
1recall

Who Else Makes It

Concentrated in Jiangsu (16), Zhejiang (15), Shanghai (11). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FMF
Manufacturer City Province Registered as Device types
Jiangsu Caina Medical Co., Ltd. Jiangyin Jiangsu Contract manufacturer 20
BQ Plus Medical Co., Ltd. Songjiang Shanghai Contract manufacturer 13
Medwell Technology Limited Dongguan Guangdong Contract manufacturer 10
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Chengdu Sichuan Contract manufacturer 10
Zhejiang Runqiang Medical Instruments Co., Ltd. Jiaxing Zhejiang Contract manufacturer 9
Wuxi Yushou Medical Appliances Co., Ltd. Wuxi Jiangsu Contract manufacturer 8
Pine Moon Electronics Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Shenzhen HYS Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 6
Yangzhou Xingwei Medical Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 5
Zhejiang INI Medical Devices Co., Ltd. Wenzhou Zhejiang Contract manufacturer 4
ShanDong WeiGao Group Medical Polymer Co., Ltd. Weihai Shandong Contract manufacturer 3
Hantech (Ningbo) Medical Technology Co., Ltd. Ningbo Zhejiang Contract manufacturer 3

Showing 12 of 60. All 60 manufacturers in China registered for Syringe, Piston

Record

Regulatory record for DMject Insulin Syringe
Listed by Shinchang Medical Co., Ltd., South Korea
FDA product code FMF
Device type Syringe, Piston
Device class Class 2
Regulation 21 CFR 880.5860
Establishment Manufacturer
510(k) K993017
Record published 2026-03-03

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date
Storage Storage environment temperature 0 to 30 °C
Packaging Shipping case of 3000, inner box of 100

Catalogue Numbers

Catalogue numbers for DMject Insulin Syringe
Catalogue number Size Status
DMject Insulin Syringe 0.5mL 30G×5/16″ In distribution
DMject Insulin Syringe 0.3mL 30G×5/16″ In distribution
DMject Insulin Syringe 1mL 31G×5/16″ In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Yeso med Wuxi Yushou Medical Appliances Co., Ltd. 228
Medallion® Merit Medical Systems, Inc. 223
Merit Medical® Merit Medical Systems, Inc. 192
Monoject Cardinal Health 188
Medline Medline Industries, Inc. 127
EasyTouch MHC Medical Products 122
Medline Industries, Inc. Medline Industries, Inc. 99
Arrow Teleflex Medical LLC 94
Ceros Rhino Medical Supply Inc 92
Enteral Feeding Medela LLC 87
Monoject Cardinal Health 200, LLC 83
HSW Soft-Ject® Henke-Sass Wolf, Gmbh. 80

Showing 12 of 913. All products under Syringe, Piston

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K993017 2000-02-25

Recalls Naming This Product

8 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of DMject Insulin Syringe
Recalled by Identified by Initiated FDA class Root cause Reason Quantity Closed
Cypress Medical Products, Ltd. 510(k) number 2018-09-04 Class II Equipment maintenance Small hole at the end of the syringe is impeding suction of liquid. 400 cases 2024-05-28
Shinchang Medical Co., Ltd. 510(k) number 2018-08-24 Class II Under Investigation by firm Defect consists of a small crack in the top end of the barrel near the needle. 6,570,800 2023-01-04
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals 510(k) number 2009-10-27 Not classified Other Needles are becoming dislodged from the barrels. 321,990 cartons of 100 2010-11-24
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals 510(k) number 2009-10-27 Not classified Other Needles are becoming dislodged from the barrels. 398,075 cartons of 100 2010-11-24
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals 510(k) number 2009-10-27 Not classified Other Needles are becoming dislodged from the barrels. 504,280 cartons of 100 2010-11-24
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals 510(k) number 2009-10-27 Not classified Other Needles are becoming dislodged from the barrels 480,045 cartons of 100 2010-11-24
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals 510(k) number 2009-10-27 Not classified Other Needles are becoming dislodged from the barrels. 254,055 cartons of 100 2010-11-24
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals 510(k) number 2009-10-27 Not classified Other Needles are becoming dislodged from the barrels. 171,421 cartons of 100 2010-11-24

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer