Jiangsu Shenli Medical Production Co., Ltd.
CHANGZHOU Jiangsu, CN
JIANGSU SHENLI MEDICAL PRODUCTION CO.,LTD appears in FDA device records in CHANGZHOU Jiangsu, CN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 87 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Jiangsu Shenli Medical Production Co., Ltd. between 2017 and 2020. The busiest year on record is 2017, with 1. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200557 | Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) | PNR | Substantially Equivalent | |
| K180259 | Sterile Hypodermic Needle for Single Use | FMI | Substantially Equivalent | |
| K163093 | Safety Blood Collection Set | FMI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003902757 | 3003902757 | JIANGSU SHENLI MEDICAL PRODUCTION CO.,LTD | No 20, Changzheng Road, CHANGZHOU Jiangsu 213111 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 87| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2128-2024 | Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2127-2024 | Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2126-2024 | Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE HEP FLUSH Model/Catalog Number: 91862 Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2125-2024 | Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE CONTRAST Model/Catalog Number: 91860 Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2124-2024 | Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-M Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2123-2024 | Brand Name: GMAX Product Name: SYR 60ML/LL Blue syringe Model/Catalog Number: TS2260LB-M Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2122-2024 | Brand Name: GMAX Product Name: SYR 10ML/LL Blue syringe Model/Catalog Number: TS2210B-M Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2121-2024 | Brand Name: GMAX Product Name: SYR 10ML Control syringe Model/Catalog Number: TS3210L-M Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2120-2024 | Brand Name: GMAX Product Name: SYR 60ML/LS syringe Model/Catalog Number: TS2260S-M Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2119-2024 | Brand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number: TS2220S-M Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2118-2024 | Brand Name: GMAX Product Name: SYR 12ML/LS syringe Model/Catalog Number: TS2212S-M Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2117-2024 | Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2116-2024 | Brand Name: GMAX Product Name: SYR 60ML/LL syringe Model/Catalog Number: TS2260L-M Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2115-2024 | Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2114-2024 | Brand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-M Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2113-2024 | Brand Name: GMAX Product Name: SYR 20ML/LL syringe Model/Catalog Number: TS2220L-M Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2112-2024 | Brand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number: TS2212L-M Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2111-2024 | Brand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number: TS2210L-M Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2110-2024 | Brand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2109-2024 | Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205L-M Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2108-2024 | Brand Name: GMAX Product Name: SYR 3ML/LL syringe Model/Catalog Number: TS2203L-M Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2107-2024 | Brand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR60L Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2106-2024 | Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR35L Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2105-2024 | Brand Name: Wolf Medical Product Name: 20 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR20L Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified | |
| Z-2104-2024 | Brand Name: Wolf Medical Product Name: 12 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR12L Product Description: NON-Sterile syringes without needles for single use Component: No | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain