Medline
Container, Sharps, 5.4QT, CLR, Wall Moun
71manufacturers in China registered for this device type
59catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (20), Zhejiang (19), Shanghai (12). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Anhui Kangda Medical Products Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Aena Medical (Jiangsu) Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 4 |
| Zhejiang INI Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Hantech (Ningbo) Medical Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 71. All 71 manufacturers in China registered for Needle, Hypodermic, Single Lumen
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| 510(k) | K970383 |
| Record published | 2026-03-19 |
| Record revised | 2025-12-10 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Store in a cool, dry place away from chemical substances. |
| Packaging | Box of 100, pack of 1000, box of 50, case of 800, case of 1000, case of 1200 |
| Sizes | Length 0.5 to 1.5 in; weight 18 to 30 g; total volume 3 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MPHPN318 | 31G, 8mm | 100 | In distribution |
| SPN311006 | 100 | In distribution | |
| SYR100227 | 100 | In distribution | |
| SYRS100217 | Length 1.5 in | In distribution | |
| MDS705254 | In distribution | ||
| DYNDMSN207 | In distribution | ||
| SYRS100272 | Weight 27 g | In distribution | |
| SYR100225 | 100 | In distribution | |
| SYRS103215 | In distribution | ||
| DYNDMSN225 | Weight 22 g | In distribution | |
| SYR100215 | 100 | In distribution | |
| SPN301008 | 100 | In distribution | |
| SYR100205 | 100 | In distribution | |
| MPHPN315 | 31G, 5mm | 100 | In distribution |
| SYRS103205 | Total Volume 3 ml | In distribution | |
| SPN301005 | 100 | In distribution | |
| SYR100197 | 100 | In distribution | |
| SSN110217 | In distribution | ||
| SPN311005 | 100 | In distribution | |
| SYRS100302 | Length 0.5 in | In distribution | |
| SYR100235 | 100 | In distribution | |
| SLIDEBR21G | In distribution | ||
| SLIDEBR23GL | In distribution | ||
| SYRS101276F | In distribution | ||
| SLIDEBCS25GL | In distribution | ||
| DYNDSBCH21G | Weight 21 g | In distribution | |
| SYR100302 | 100 | In distribution | |
| DYNDSBCH22G | Weight 22 g | In distribution | |
| SYRS100273 | Weight 27 g | In distribution | |
| SLIDEBR21GL | In distribution | ||
| SYRS100257 | In distribution | ||
| SYRS100237 | Length 1.5 in | In distribution | |
| SYR100207 | 100 | In distribution | |
| DYNDSBCHLDR | 25 | In distribution | |
| MDS705253 | In distribution | ||
| DYNDMSN215 | Weight 21 g | In distribution | |
| SYR100185 | 100 | In distribution | |
| DYNDLA | In distribution | ||
| SSN101255F | In distribution | ||
| SYRS103207 | In distribution | ||
| SYR100255 | 100 | In distribution | |
| ACSD | In distribution | ||
| DYNDMSN217 | Weight 21 g | In distribution | |
| SYR100253 | 100 | In distribution | |
| SYR100167 | 100 | In distribution | |
| SSN103253 | In distribution | ||
| SSN101235F | In distribution | ||
| DYNDSBCN21G | Length 1.25 in | In distribution | |
| SYRS100235 | In distribution | ||
| SYR100257 | 100 | In distribution | |
| SYR100187 | 100 | In distribution | |
| DNSC102965A | Weight 18 g | In distribution | |
| SLIDEBCS23GL | In distribution | ||
| DYNDSBCN22G | Weight 22 g | In distribution | |
| SYRS100215 | Weight 21 g | In distribution | |
| SLIDEBR23G | In distribution | ||
| SYR100195 | 100 | In distribution | |
| SSN110227 | In distribution | ||
| SLIDEBR25G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterile Single-use Syringe with Needle | Jiangxi Hongda Medical Equipment Group Ltd. | 162 |
| Tkmd | Anhui Tiankang Medical Technology Co., Ltd. | 150 |
| Reli | Myco Medical Supplies, Inc. | 149 |
| STERiJECT TM | TSK Laboratory, Japan | 140 |
| Yeso med | Wuxi Yushou Medical Appliances Co., Ltd. | 130 |
| Monoject | Cardinal Health | 124 |
| Monoject | Cardinal Health 200, LLC | 112 |
| Jelco | ICU Medical, Inc | 108 |
| micsafe | Jiangsu Micsafe Medical Tehcnology Co., Ltd. | 105 |
| McKesson | Mckesson Medical-Surgical Inc. | 93 |
| EasyTouch | MHC Medical Products | 82 |
| Medegen Medical products | Medegen Medical Products | 78 |
Showing 12 of 797. All products under Needle, Hypodermic, Single Lumen
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K062984 | 2006-11-13 |
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.