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…
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
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.
| 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
| 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
| 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 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
| 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
| 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.
| 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.