K-Pack II
K-Pack II Needle
71manufacturers in China registered for this device type
42catalogue numbers in this listing
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 | Terumo Europe NV |
|---|---|
| FDA product code | FMI |
| Device type | Needle, Hypodermic, Single Lumen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5570 |
| 510(k) | K984576 |
| Record published | 2016-09-05 |
| Record revised | 2026-01-12 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight. Keep dry.; Storage environment temperature 2 to 30 °C |
| Packaging | Carton of 5000, carton of 10, shelfbox of 500, carton of 50, shelfbox of 50, carton of 4 |
| Sizes | Needle gauge 18 to 30 G |
| Distribution end date | 2025-07-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KN-2238RB | Thin wall | In distribution |
| KN-2038RB500P | Needle Outer Diameter: 0.9 Millimeter | In distribution |
| KN-2719RB500P | Needle Outer Diameter: 0.4 Millimeter | In distribution |
| KN-2913RBKT | Needle Outer Diameter: 0.33 Millimeter | In distribution |
| KN-2908RBKT | Thin Wall | In distribution |
| KN-2525RB | Needle Length: 1 Inch | In distribution |
| KN-2713RBR | Needle Length: 12 Millimeter | In distribution |
| KN-2713RBK | Needle Gauge 27 G | In distribution |
| KN-3013RBKT | Needle Length: 0.5 Inch | In distribution |
| KN-1838SBS | Short Bevel | In distribution |
| KN-2325RB04 | Thin wall | In distribution |
| KN-2150RB | Needle Length: 2 Inch | In distribution |
| KN-2913RB | Needle Length: 0.5 Inch | In distribution |
| KN-2138RB | Needle Length: 1.5 Inch | In distribution |
| KN-2719RBT | Needle Length: 0.75 Inch | In distribution |
| KN-2610RB | Needle Length: 0.375 Inch | In distribution |
| KN-2138RB04 | Needle Length: 1.5 Inch | In distribution |
| KN-2516RB04 | Needle Length: 0.625 Inch | In distribution |
| KN-2038RB | Needle Gauge 20 G | In distribution |
| KN-2713RB | Needle Length: 0.5 Inch | In distribution |
| KN-2325RB | Thin wall | In distribution |
| KN-2516RB05 | Needle Length: 0.625 Inch | In distribution |
| KN-3013RBKE | Needle Outer Diameter: 0.3 Millimeter | In distribution |
| KN-1938RB | Needle Length: 1.5 Inch | In distribution |
| KN-2525RB04 | Needle Length: 1 Inch | In distribution |
| KN-2913RBS | Needle Length: 12 Millimeter | In distribution |
| KN-2332RB | Needle Length: 1.25 Inch | In distribution |
| KN-1838SB | Needle Length: 1.5 Inch | In distribution |
| KN-2713RB500P | Needle Gauge 27 G | In distribution |
| KN-2713RBKTE | Needle Outer Diameter: 0.4 Millimeter | In distribution |
| KN-2713RBKT | Needle Length: 0.5 Inch | In distribution |
| KN-3013RBKU | Needle Outer Diameter: 0.3 Millimeter | In distribution |
| KN-2616RB | Needle Length: 0.625 Inch | In distribution |
| KN-3013RB | Needle Length: 0.5 Inch | In distribution |
| KN-2232RBB | Needle Length: 30 Millimeter | In distribution |
| KN-2232RB | Needle Length: 1.25 Inch | In distribution |
| KN-2713RBKTU | Needle Outer Diameter: 0.4 Millimeter | In distribution |
| KN-2719RB | Needle Length: 0.75 Inch | In distribution |
| KN-2713RKT50 | Neede Length: 0.5 Inch | Withdrawn |
| KN-2719RBTS | Needle Length: 0.75 Inch | Withdrawn |
| KN-2713RBKT50 | Needle Length: 12 Millimeter | Withdrawn |
| KN-3013RKT50 | Needle Outer Diameter: 0.3 Millimeter | 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
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.