Profi Disposable Syringe

1. Disposable Syringe 2. Intended use : To inject fluids into or withdraw fluids out of the body. 3. Instructions for use 1) Expose needle by removing needle cover. 2) Inject the fluid into…

Registry build 21.09.26

1. Disposable Syringe 2. Intended use : To inject fluids into or withdraw fluids out of the body. 3. Instructions for use 1) Expose needle by removing needle cover. 2) Inject the fluid into syringe by pulling plunger 3) After injecting the injection fluid into the syringe, inject into disinfected area by pushing plunger. 4) After injecting the fluid into the affected area, withdraw the syringe from needle and dispose immediately(“Do not reuse”) 4. Warning 1) This product is single use device, therefore it must be disposed after its use 2) Do not reuse after suction the medicines. 3) Do not use individual packages that are opened or damaged because sterilization is not guaranteed. 4) Do not use damaged or bent needle before use. 5) Do not use the product when it finds foreign substances before use 6) To prevent secondary contamination, open the package before use. 7) Do not use the product except general injection purposes. 8) Do not attempt to close the needle cover after use. If you are pierced by contaminated needle, various infections can infected 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 : 3 years from manufacturing date

60manufacturers in China registered for this device type
9catalogue 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 Profi disposable 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 2021-05-04
Record revised 2024-03-11 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, manufacturing date
Storage Storage environment temperature 0 to 30 °C
Packaging Inner box of 100, outer box of 3000, outer box of 1600, outer box of 2400

Catalogue Numbers

Catalogue numbers for Profi disposable syringe
Catalogue number Size Status
Profi disposable syringe 5mL 23G×1″ In distribution
Profi LDS syringe 1mL 23G×1″ In distribution
Profi disposable syringe 3mL 23G×1″ In distribution
Profi disposable syringe 5mL 23G×1″ In distribution
Profi disposable syringe 3mL 23G×1″ In distribution
Profi LDS syringe 1mL 26G×1″ In distribution
Profi disposable syringe 1mL 23G×1″ In distribution
Profi disposable syringe 1mL 23G×1″ In distribution
Profi LDS syringe 1mL 25G×1″ 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 Profi disposable 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