Needle, Hypodermic, Single Lumen
Sharps Coll Next GEN 5.4QT Pearl 12/PACK
71manufacturers in China registered for this device type
76catalogue numbers in this listing
12510(k) clearances naming this product code
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 | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K021475 |
| Record published | 2016-09-16 |
| Record revised | 2025-08-06 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Room Temperature |
| Packaging | Case of 10, pack or inner pack of 100, shelfpack of 50, case of 6, case of 5, case of 5000 |
| Sizes | Length 0.375 to 2 in; needle gauge 16 to 30 G; height 0.5 to 1.5 in; total volume 18.7 to 72 l |
| Distribution end date | 2023-03-29 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 305190 | Needle Gauge 21 G | In distribution | |
| 305195 | 100 | In distribution | |
| 305120 | Length 1.25 in | In distribution | |
| 305100 | 8 | In distribution | |
| 305193 | Needle Gauge 23 G | In distribution | |
| 305165 | Length 1 in | In distribution | |
| 305128 | Length 1 in | In distribution | |
| 302895 | Needle Gauge 21 G | 20,000 | In distribution |
| 302892 | Needle Gauge 26 G | 16,000 | In distribution |
| 305428 | 12 | In distribution | |
| 305159 | Length 1.5 in | In distribution | |
| 301695 | Needle Gauge 22 G | In distribution | |
| 305196 | Length 1.5 in | In distribution | |
| 305156 | Length 1.5 in | In distribution | |
| 305111 | Height 0.5 in | In distribution | |
| 305178 | Length 1 in | In distribution | |
| 305186 | 100 | In distribution | |
| 305125 | Needle Gauge 25 G | In distribution | |
| 305187 | Height 1.5 in | In distribution | |
| 305122 | Length 0.625 in | In distribution | |
| 302884 | Needle Gauge 30 G | 20,000 | In distribution |
| 305197 | Height 1 in | In distribution | |
| 305328 | Total Volume 72 l | In distribution | |
| 305330 | 20 | In distribution | |
| 305155 | Length 1 in | In distribution | |
| 305188 | 100 | In distribution | |
| 305577 | In distribution | ||
| 305177 | Needle Gauge 21 G | In distribution | |
| 305185 | Needle Gauge 18 G | In distribution | |
| 305078 | 12 | In distribution | |
| 305176 | Needle Gauge 20 G | In distribution | |
| 302885 | Needle Gauge 27 G | 20,000 | In distribution |
| 305145 | Length 1 in | In distribution | |
| 305129 | Needle Gauge 21 G | In distribution | |
| 305110 | Length 0.375 in | In distribution | |
| 301629 | Needle Gauge 27 G | In distribution | |
| 305136 | 100 | In distribution | |
| 305175 | Needle Gauge 20 G | In distribution | |
| 305633 | In distribution | ||
| 305189 | Length 1.5 in | In distribution | |
| 302900 | 16,000 | In distribution | |
| 302890 | Needle Gauge 30 G | 20,000 | In distribution |
| 301630 | Needle Gauge 23 G | In distribution | |
| 305147 | 36 | In distribution | |
| 301692 | 100 | In distribution | |
| 303369 | In distribution | ||
| 305151 | 12 | In distribution | |
| 302891 | Length 0.875 in | 20,000 | In distribution |
| 305127 | Needle Gauge 25 G | In distribution | |
| 305179 | Length 1.5 in | In distribution | |
| 305199 | Length 1.5 in | In distribution | |
| 305166 | Height 1.25 in | In distribution | |
| 305167 | Length 1.5 in | In distribution | |
| 305143 | Length 0.75 in | In distribution | |
| 304142 | In distribution | ||
| 305194 | Length 1.5 in | In distribution | |
| 302894 | 20,000 | In distribution | |
| 305115 | 100 | In distribution | |
| 305550 | In distribution | ||
| 305557 | In distribution | ||
| 305114 | Total Volume 18.7 l | In distribution | |
| 305198 | Needle Gauge 16 G | In distribution | |
| 305124 | Needle Gauge 25 G | In distribution | |
| 305109 | Height 0.5 in | In distribution | |
| 305106 | Length 0.5 in | In distribution | |
| 305142 | 100 | In distribution | |
| 305423 | 10 | Withdrawn | |
| 305079 | 10 | Withdrawn | |
| 305149 | 12 | Withdrawn | |
| 305776 | Withdrawn | ||
| 305775 | Withdrawn | ||
| 300470 | 12 | Withdrawn | |
| 300473 | 8 | Withdrawn | |
| 300467 | 12 | Withdrawn | |
| 305777 | Withdrawn | ||
| 305148 | 24 | Withdrawn |
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 |
|---|---|
| K223286 | 2022-12-28 |
| K213478 | 2022-06-28 |
| K213156 | 2021-12-08 |
| K212015 | 2021-11-19 |
| K181730 | 2019-03-01 |
| K182320 | 2018-12-20 |
| K170824 | 2018-08-20 |
| K162516 | 2016-12-09 |
| K161553 | 2016-07-06 |
| K161170 | 2016-05-27 |
| K110703 | 2011-07-27 |
| K100005 | 2010-04-15 |
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | 510(k) number | 2020-11-18 | Class II | Under Investigation by firm | BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2″ Lot No. 9128897. The possibility of infection may be present if the blood is not noticed prior to use by the clinician. | 1,430,000 | 2024-02-15 |
| Becton, Dickinson & Co. | 510(k) number | 2017-05-31 | Class II | Process control | Hub damage resulting in breakage and/or leakage during use. | 2,598,000 units | 2018-06-28 |
| Becton, Dickinson & Co. | 510(k) number | 2016-12-20 | Class II | Device Design | BD is initiating a Product Advisory for the Eclipse Hypodermic Needle because of safety complaints covering disengagement and needlestick injuries. | 263 mm units | 2018-04-20 |
| Becton, Dickinson & Co. | 510(k) number | 2011-10-08 | Not classified | Device Design | Becton Dickinson has identified clogged needles. | 480,000 units | 2012-12-11 |
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.