ACU-Needle
18 standard gauge 1 1/2" needle, high quality economical plastic hub hypodermic needles. Fits both luer slip and luer lock syringes, tri-beveled tip. Sterile
71manufacturers in China registered for this device type
34catalogue 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 | Acuderm, Inc., United States |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K874024 |
| Record published | 2020-01-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| NP301 | 100 | In distribution | |
| NP315 | 100 | In distribution | |
| 0NP315 | In distribution | ||
| 0NP1815 | In distribution | ||
| 0NP2015 | In distribution | ||
| NP2115 | 100 | In distribution | |
| NP335 | 100 | In distribution | |
| 0NP2115 | In distribution | ||
| 0NP2558 | In distribution | ||
| 0NP335 | In distribution | ||
| 0NP301 | In distribution | ||
| NP1815 | 100 | In distribution | |
| NP2215 | 100 | In distribution | |
| 0NP2210 | In distribution | ||
| NP1810 | 100 | In distribution | |
| 0NP271 | In distribution | ||
| 0NP2510 | In distribution | ||
| NP2210 | 100 | In distribution | |
| 0NP2310 | In distribution | ||
| 0NP2110 | In distribution | ||
| 0NP1810 | In distribution | ||
| NP2210 | 100 | In distribution | |
| 0N2235 | In distribution | ||
| NP2510 | 100 | In distribution | |
| NP2558 | 100 | In distribution | |
| 0NP325 | In distribution | ||
| NP2010 | 100 | In distribution | |
| NP325 | 100 | In distribution | |
| N2235 | 50 | In distribution | |
| NP2015 | 100 | In distribution | |
| 0NP2215 | In distribution | ||
| 0NP2010 | In distribution | ||
| NP271 | 100 | In distribution | |
| NP2110 | 100 | 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 |
|---|---|
| K874024 | 1987-11-23 |
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.