LDV Syringe 1ml/cc X 1FT X FDN38 (23g X 38.1mm)
Catalogue number 1FT x FDN38, listed by Feeltech Co., Ltd., South Korea, under Low Dead Space Piston Syringe. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (2), Shanghai (2), Anhui (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Kindly Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Shanghai Kindly Enterprise Development Group Co., Ltd. | Jiading | Shanghai | Contract manufacturer | 11 |
| Shanghai Mekon Medical Devices Co., Ltd. | Shanghai | Shanghai | Exporter | 11 |
| Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | Taihu | Anhui | Contract manufacturer | 8 |
| Zhejiang Longde Pharmaceutical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
Record
| Listed by | Feeltech Co., Ltd., South Korea |
|---|---|
| FDA product code | QNQ |
| Device type | Low Dead Space Piston Syringe |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K092831 |
| Record published | 2024-12-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Inbox of 100, carton box of 3000 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1FT x FDN38 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LDV (Low Dead Volume) Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 3 |
| LDV Syringe 1mL/cc x 1FT x FDN3 (23G x 25mm) | Feeltech Co., Ltd. | 1 |
| LDV Syringe 1mL/cc x 1FT x FDN24 (25G x 25.4mm) | Feeltech Co., Ltd. | 1 |
| SOL-M Slip Tip Syringe 1 ml without needle (LDS) | Sol-Millennium Medical, Inc. | 1 |
| SJJ | Prosum Medical Limited | 1 |
| SOL-M 1ml Slip Tip Syringe w/o needle (low dead space) | Sol-Millennium Medical, Inc. | 1 |
| SOL-Care 1ml Luer Lock Syringe w/Safety Needle 25G*5/8 | Sol-Millennium Medical, Inc. | 1 |
| LDV Syringe 1mL/cc x 1FT x FDN37 (25G x 38.1mm) | Feeltech Co., Ltd. | 1 |
| LDV Syringe 1mL/cc x 1FTIFDN7 (30G x 5/16) | Feeltech Co., Ltd. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213010 | 2023-05-31 |
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.